Regular readers know that, as a cancer surgeon, I become particularly worked up about stories of naturopaths taking care of cancer patients, which all too often end in disaster for the patient. I've lost count of how many naturopaths I've seen, either on their websites, in talks, or in published literature, claiming that they can cure cancer "naturally," using any of a number of unproven methods, an example being the Gerson protocol, a form of quackery involving 13 larges glasses of raw vegetable and fruit juice, around 150 supplements, and five coffee enemas a day, each and every day. Others have claimed that "chemotherapy is for losers," and frequently use alternative treatments associated with a much higher chance of dying of cancer. It's no wonder how alarmed I am that naturopaths have created a pseudo-specialty patterned after medical oncology that they call "naturopathic oncology," complete with an abbreviation (FABNO, or, as I like to put it, "FAB? NO!"). They even pretend that it's a real medical specialty, despite all the pseudoscience and quackery involved, when in reality it's just quacks cosplaying real oncologists. It drives me even more crazy to see doctors who should really know better collaborating with naturopaths and then taking self-righteous umbrage when it is pointed out that they are betraying their duty to patients by collaborating with quacks, mainly because they don't realize that naturopathy is so rooted in pseudoscience that you can't have naturopathy without homeopathy, which is an integral part of it.

So it was with dismay and anger that I discovered that someone whom I consider a friend and most certainly admire for her ability to admit a huge mistake and change course is being targeted for legal thuggery by a "naturopathic oncologist." I'm referring, of course, to ex-naturopath Britt Hermes, who a few years ago came to the startling realization that she was a quack and actually had the courage to give up her profession as a naturopath and undertake studies to become a real scientist. (Seriously, you really should read her blog, Naturopathic Diaries. It's an insider account that should end all doubt that even "respectable" licensed naturopaths practice quackery.) As a result of her dishing on her ex-colleagues and exposing the pseudoscience in her previous profession, naturopaths really, really hate her. In this case, a prominent "naturopathic oncologist," Colleen Huber, has served her with a cease and desist letter. It's not the first time naturopaths have tried legal thuggery; just a month and a half ago, Bastyr University (a.k.a. the Harvard of naturopathy schools, which is not a good thing, by the way) served her with a similar legal nastygram. It all came about because Hermes came to what looks to me like a reasonable conclusion based on circumstances that Huber had cybersquatted her name by buying up domain names based on her name, setting them up to redirect to the homepage of the American Association of Naturopathic Physicians:

The Wix account of BrittMarieHermes.com is registered with an email address at the domain natonco.org, the official website for the Naturopathic Cancer Society and a non-profit organization in Tempe, Arizona run by naturopathic cancer “doctor” Colleen Huber, NMD and her surrogate Hazel Chandler. The organization raises money for cancer patients who desire to use, but cannot afford, expensive alternative cancer therapies such as intravenous vitamins, mistletoe injections, and special diets, which is then funneled to Huber’s clinic Nature Works Best and others.

Hermes had also pointed out how Huber's claims about her success rate were utterly risible, which apparently stung her, but there's no denying it: They are. (I'll get to why in a moment.) First, though, let's take a look at what Huber claims. I perused her website again (NatureWorksBest), having encountered it before. The first thing one encounters on the splash page of her website are these claims:

Nature Works Best is a natural cancer clinic located in Tempe, Arizona, that focuses on natural, holistic, and alternative cancer treatments. Our treatments have proved to be an effective alternative to traditional chemotherapy and radiation, which we do not use in our treatments. Rather, we have developed a natural method of treating cancers based on intravenous vitamin therapy which may include Vitmain-C, Baking Soda, and other tumor fighting agents as well as a simple food plan. Our team of naturopathic medical doctors have administered over 26,000 intravenous treatments, used for all stages and types of tumors. As of July 2014, 80% of patients who completed our treatments alone went into remission, 85% of patients who completed our treatments and followed our food plan went into remission; 93% of patients in Stage I through early Stage 4 who did all of our protocols went into remission. No other clinic, of any kind, has such a high documented success rate. Our cancer clinic treats all types of malignancies, at all different stages, often with different co-morbidities, and different patterns of metastases. We have seen patients of all stages do very well with our treatments, with the exception of late stage IV patients.

So many red flags, and I haven't even gotten past the first page! Intravenous vitamin C? It almost certainly doesn't work. Even the most charitable interpretation of existing evidence is that, at best and giving every benefit of the doubt, it has a very, very modest antitumor effect, too weak to be of much use. Basically, there's some in vitro and animal model work that suggests a modest effect against a few tumors, but none of it has been translated into humans. Even if the best possible scenario came out of human clinical trials, high dose intravenous vitamin C for cancer is, as I like to call it, a very long run for a very short slide.

Intravenous baking soda (sodium bicarbonate) is another favorite. The first time I ever heard of its being used was by a particularly ridiculous cancer quack named Tullio Simoncini, who claimed that all cancer is in reality a fungus and that the way to cure cancer is to kill the fungus. And how do you do that? By injecting baking soda into it. I kid you not. Simoncini is so divorced from reality that he claims that all cancer is white, like fungus, apparently never having heard of melanoma or other tumors that are a color other than white, or, for that matter, of the many variety of colors of fungi.

Guess what? Huber goes all-in for Simoncini, too, mentioning him in the very first paragraph of her page on intravenous sodium bicarbonate. After reading partway through her ridiculous pseudoscientific treatise on bicarbonate and cancer, I laughed out loud when I came to this part:

As for whether cancer is fundamentally a kind of fungus, the jury is still out. However, it is useful to know that not only does sodium bicarbonate disrupt the comfortable environment of tumors, but it also has anti-fungal effect.[4]

This, after only chuckling a little at this:

Earlier researchers have found a concurrence between cancer and candida. In Dr. Simoncini’s book, Cancer is a Fungus[3] he notes some similarities between the two. Primarily, both are intractable diseases, each very hard to get rid of. Dr. Simoncini notes that each forms a solid mass of low penetrability, unlike the dispersed forms of bacterial and viral infections in the body or body fluids. Dr. Simoncini notes the problem of surface area in addressing these infections. Whereas bacterial and viral infections are dispersed in the solutions of bodily compartments, and likewise, antibiotics and other anti-microbials dispersed in the same solutions have access to each microbe.

No, the "jury" is not "still out." Cancer is not a fungus. It is not a kind of fungus. It is the body's own cells freed from normal regulatory constraints that regulate them into doing what they're supposed to do, growing as much as they need to grow for development and tissue repair and then stopping, and functioning the way they're supposed to function. In any case, at least one patient is known to have died as a direct result of Simoncini's treatments.

Like many naturopaths, Huber takes a germ of a biologically plausible idea and runs her patients right off the cliff with it. That idea is based on the observation that many cancers exist in an acidic milieu. Much of the reason for this is that they often outgrow their blood supply and therefore exist in a hypoxic (low oxygen) environment. Also, because of the Warburg effect, many tumors exist largely on anaerobic (no oxygen) metabolism, which generates a lot of lactic acid. The idea is that perhaps by reversing the acidity the tumors might become less aggressive—or at least more sensitive to chemotherapy. There are even a few studies in mice (like this one, one of whose co-authors I know personally) that suggest treatment with IV bicarbonate can decrease metastases, although the primary tumors appear to grow at the same rate. At least one other alkalinizing agent appears to have similar effects on tumor growth.

The problem is that the studies are all pretty much in cell culture and rodent tumor models. There is no good clinical evidence that alkalinization works against cancer in humans yet. Steve Novella found a clinical trial at the University of Arizona that closed in 2015, but no results have been published yet. I note that this was a phase I trial, which means it wasn't even designed to demonstrate efficacy, just safety and patient tolerance of the regimen. It also involves only oral bicarbonate dosing, which is not what Huber is doing and would be expected to produce a much more limited alkalosis than her protocol. Even if it did, based on the modest effects observed in mice, it is incredibly unlikely that high dose bicarbonate would cure any cancers, which is what Huber claims for her treatments. At best, it might slow down tumor growth, and there are lots of problems with chronic alkalinization of the blood. Thus, I view Huber's claims very skeptically.

Of course, like all naturopaths, Huber claims her treatments are "individualized":

The intravenous nutrients are tailored specifically to each patient’s condition and chosen for their targeted, time tested, and research-documented anti-cancer, or tumor fighting effect. The nutrients we use are different for each patient, but some of nutrients used may include a combination of Vitamin-C, Sodium Bicarbonate, DMSO, in addition to many others. Before we have done a full workup we cannot know which of these nutrients may be used for your treatment, if they are used at all. These treatments are made specifically for each patient, their type and stage of malignancy and may be used exclusively or as a supplement to chemo and radiation.

Of course, who knows how Huber figures out which patient should get which treatment. This is, as I like to call it, the "make it up as you go along" method.

Huber is also very much a believer in the idea that sugar somehow "feeds" cancer. While it is true that, thanks to the Warburg effect, many tumors (but not all) actually do utilize a lot more glucose than normal tissue (if it weren't true, PET scans that use labeled glucose wouldn't be able to visualize tumors), there is no good evidence that sugar "feeds" cancer in the way that Huber and other naturopaths claim or that decreasing sugar intake decreases the growth rate of established cancers and the risk in healthy people of getting cancer, at least if you control for obesity, which does produce an increased risk of several cancers and can, of course, result from consuming too much sugar. It's also true that diabetes appears to be associated with a higher risk of certain cancers, such as pancreatic cancer. However, that increased risk appears to derive from abnormalities in the function of insulin and insulin-like growth factors.

Perhaps the most outrageous bit of nonsense on Huber's entire website is her attempt to do clinical research. On the one hand, I almost feel as though I should give her credit for trying (like a participation trophy to a child), but on the other hand she's just so bad at it. We can see for ourselves in her paper, Cancer Patients’ use of Sweeteners: A 7-Year, Controlled Study, published in 2016 in the International Journal of Cancer Research and Molecular Mechanisms.

First of all, it's one of the oddest papers I've ever seen. The description of the methodology is beyond cursory, and there is basically zero statistical analysis or anything resembling a trial design. It is "controlled" only in the sense that that the letters line up on the page in fully justified paragraphs. Seriously. This is the whole description of her methods:

Mortality vs survival was recorded of sweetened food eaters among outpatients with a cancer diagnosis at one clinic. Since 2006, this clinic has recorded data on consumption of sugar and other sweeteners in cancer patients, and has consistently recommended, but never mandated, avoidance of sweetened foods, except with extracts of the plant Stevia rebaudiana, which does not contain saccharides or sugar alcohol. is clinic has no inpatient facilities and no food service. All patients selected and purchased all of their own food, all of which originated from and was almost entirely consumed outside of the clinic. Data from all 317 consecutive patients with a diagnosis of cancer from outside of the clinic are reported in this interventional study, excluding only those cancer patients who chose to forgo further treatment a er less than two weeks in treatment.

Natural methods such as intravenous nutrients with cancer-disrupting e ect were the only ones o ered, choosing among both oral and intravenous, herbal and nutritional interventions, choosing those that patients found tolerable and that we observed to work synergistically, adjusting for individual tolerances and requirements, in accordance with the naturopathic principle of “Treat the whole person”.

After Huber's most cursory of cursory methods section, the text devolves into commentary before coming around to report Huber's "results":

Achievement of remission was quite different for the following two categories: all patients: 151/317=48% and those who ate sweetened foods: 9/29=31%. The difference between these two groups was much stronger for the cohort of patients who continued treatments until either remission or death. Comparing all patients who were steadfast in the recommended treatments with the sweetened food eaters who were steadfast in all but dietary recommendations, 151/183=83% of all completely steadfast patients achieved remission, but only 9/25=36% of the steadfast sweetened food eaters achieved remission. Remission was defined as no visibly active tumor on MRI imaging of the same area that had previously active tumor growth. Of all patients who were steadfast in the treatments (including the sweetened food eaters), 32/183=17% died while still under the care of the clinic, but considering only the sweetened food eaters who otherwise consistently pursued the recommended treatments, 16/25=64% died.

Several tables are presented, which you can peruse on your own. There's no statistical analysis, no power analysis, no hazard ratios presented, no meaningful analysis of any kind. There is no breakdown of how many patients had what kind of cancer or what stage they were. Wait, that's not quite true. Tables 4-6 break down the cases by stages (I, II, III, early stage IV and late stage IV). I note that we generally don't break down cases in such papers by "early" or "late" stage IV. Stage IV is stage IV. Also, lumping together cases of different cancer by stage is utterly meaningless. After all, a stage II pancreatic cancer is a much different beast than a stage II breast cancer, the former having a low survival rate and the latter a very high survival rate. Different mixes of different cancers per stage could produce very different results without any biological effect whatsoever due to her interventions.

Then there's this:

Many patients voluntarily left our practice, against our advice, primarily for financial reasons, while still having cancer. Of the remaining patients, 175 either went into confirmed, complete remission, which we define by no evidence of cancer remaining in the body on imaging, or have remained in good to excellent wellbeing, as determined retrospectively by prolonged stable health of at least 6 months after leaving our care and needing no other physician supervised cancer care, and as confirmed by annual telephone conversation with either the patient or a family member. Those patients in remission stayed in our care an average of 3.7 months; those who left, 2.7 months, (this data last measured in 2010). Eight additional patients went into remission after leaving our clinic, and while being treated at a different clinic, and it is unlikely that our treatments were the decisive factor in that remission. We were still treating 22 patients at July 1, 2014 plus giving ongoing maintenance treatments to some of those who are still in remission. 44 died while still our patients. Of those 44, 12 died after a significant dietary dispute with us. That is 32 patients died although they received our treatments and complied with our requested diet. 22 more were killed by hospital procedures and/or chemotherapy and/or radiation side effects while still our patients. 45 total patients chose to have chemotherapy while having our treatments. Yet, of the 175 who went into remission, only 12 had chosen to have chemotherapy while having our treatments. Stages 1, 2, 3 and early Stage 4 patients at start of treatment had much better outcomes than late Stage 4 patients in general.

In her paper, she lists 151/317 patients as in "remission or assumed remission." My reaction? You can't "assume" remission. Either the patient is in remission or he isn't. She also lists 20 "iatrogenic deaths in the hospital or by MDs." Really? How do you define "iatrogenic"? Or are these patients who gave up because Huber's treatments weren't working? Who knows? It is known that a high dropout rate is a red flag in any clinical study. Also, over 1/3 of the patients listed in Table 1 received surgery or chemotherapy, leading one to wonder how much of any good results reported was due to actual conventional treatment.

I also noticed while poking around Britt's website that Huber had published her "methods" (such as they are) on her website a couple of years earlier. Funny, but she also left out a lot of this in her paper. She also left out a fair number of patients who received radiation therapy (Table I). Why did she not include these numbers in her published paper? One wonders, one does. I also can't help but mention another analysis by Thomas Mohr, who looked at Huber's numbers and posted his reaction in a comment on Britt's blog about a version of Huber's study posted before the final published version:

The data are difficult to estimate but from the overall table one can conclude that there is complete information for 247 patients (excl iatrogenic deaths, unknown status, etc). Of these 78 died. Of these 13 died in the state of the art treatment arm and 65 died in the naturopathy arm (the numbers are estimated due to the lack of a both surgery and chemotherapy group, I assumed 50 to be in the state of the art treatment arm, accounting for 50% overlap between surgery and chemotherapy). Putting aside the ethical issues of the extremely bad study design, the lack of ethics committee approval or patients agrrement, a quick n' dirty analysis of the data reveals following odds ratio: 2.1 (95% CI 1.01 - 4.40, p<0.05) in favour of state of the art treatment. I.o.W. patients under natural care only have a more than twofold higher risk to die.

And:

An addendum. If one removes data of questionable quality and takes into account only those with complete data and in treatement resp. died during treatment (i.e. in remission, not yet in remission, died) , the odds ratio gets almost 10:1 in favour of state of the art therapy. This is really nasty.

Indeed it is, also unethical as hell. This paper is so bad that it could be used as an example of how not to do clinical research. In addition, there is no listing of an institutional review board (IRB) approval, appropriate informed consent to patients who filled out her questionnaires, or any of the other usual practices designed to protect patients. Even more despicable is her claim in her "cease and desist" letter to Britt Hermes:

Huber claims her research has been registered with the Office of Human Research Protections and the FDA since 2013.

Huber claims her study is a retrospective case series that does not require IRB approval.

Huber claims her IRB has extensive and definitive policies regarding informed consent, HIPAA laws, and protection of human research subjects.

If the first were the case, Huber could show her IRB approval. Also, an investigator doesn't have to register a human trial with the FDA unless he's seeking FDA approval for the investigational agent being studied. As for the second, Huber is just plain wrong. Retrospective case series do require IRB approval. Period. This is not even a gray area. True, some of them depending on the details, might qualify for an expedited review by the IRB, but from what I can tell Huber's would probably not have qualified because it uses protected patient information. As for her claimed IRB, Britt did a long post for Science-Based Medicine showing naturopathic IRB shenanigans of the Arizona naturopathic IRB formed by Huber and others.

Basically, Huber is unhappy that Britt has been kicking up the rocks and shining light on the quackery practiced by naturopaths and the unethical and incompetent clinical trials being done by them to try to provide a veneer of scientific respectability to their quackery. As a result, she's acted like so many other dubious practitioners and, instead of defending herself with science, has tried to silence critics with legal thuggery.