A couple weeks ago, I got a second cease and desist letter. Bastyr University sent the first, but the latest was sent by a naturopath in Tempe, Arizona by the name of Colleen Huber. Just so you know right away the type of person I’m dealing with, she’s been claiming that “her clinic, Nature Works Best Cancer Clinic, has had the most successful results of any clinic in the world.”
Quick background on Colleen Huber
Colleen Huber does not use conventional chemotherapy or radiation. She treats cancer with intravenous baking soda, vitamin C, and other “natural” substances, while instructing patients to cut out sugar from their diets. She thinks sugar feeds cancer.
Huber conducts research in her private practice that is alleged to be investigating cancer patient survivability based on whether they complete her treatments and adhere to a strict sugar-free diet. Since October 2006, the same year she became licensed after graduating from the Southwest College of Naturopathic Medicine, she started collecting data on her cancer patients for what she describes as a “controlled interventional study.” She has self-published a series of her “research” annually since 2009, and more recently her work has appeared in open-access, predatory journals that seem like they pander to cancer quackery (here, here, and here). In her own words, this is how she designed her on-going study on sugar and cancer:
So the patients were not randomized. They chose to have natural treatments or not. If they chose the natural treatments, they were included in our study. They chose to have chemotherapy or not. And they chose to follow our recommendation to avoid sweetened foods or not.
However, they were controlled in that the single independent variable – avoidance of sweetened foods was the variable that we examined (inasmuch as you can control other variables in an outpatient clinic.)
We remember that “in a controlled experiment, no treatment is given to the control group, while the experimental group is changed according to some key variable of interest, and the two groups are otherwise kept under the same conditions.”
Compliance was treated as a dichotomous variable, so participants were considered to be either compliant or non-compliant. Therefore, compliance (or not) is the variable.
All patients in the study received the recommended intravenous nutrients chosen for antineoplastic effect. What differed and what was studied was how those who received those IV treatments and avoided sugar differed from those who had those IV treatments and consumed sugar.
Wow. This all seems like bullshit research. In fact, the closer one looks, the worse it gets.
Nowhere in any of her “research” that I could find did she write that she obtained written, informed consent from her patients/research subjects. Nor did she write that her “research” was approved by an Institutional Review Board (IRB) or was registered with ClinicalTrials.gov. These are fundamental ethical requirements for research on human subjects.
But don’t worry, Colleen Huber is a founding member of a naturopathic Institutional Review Board that has apparently approved her research. The board, which also oversees several other naturopathic organizations, including the Naturopathic Oncology Research Institution (NORI), was established in 2010, and from what I can tell, was registered with the FDA in 2013. This registration is legally required in order to approve research on human subjects. According to the IRB’s meeting minutes from November 8, 2013, the first study approved was a study on an herbal gel for cold sores. But Huber says she started her research in 2006…before her IRB was formed.
If you were concerned that an IRB run by naturopaths may be highly suspicious, I encourage you to read a post I wrote at Science-Based Medicine about the group. But here are some snippets from their meeting minutes that are revealing:
- the purpose of this organization is not to restrict the practices of the members but rather to affirm and uphold all therapies that offer more potential benefit to patients than risk, as well as encouraging and educating patients in their options, so that they are able to make the best decisions they can. (February 5, 2010)
- We have also come together in order to preserve naturopathic medicine, as practiced in all the diversity, comprehensiveness, synergy and breadth of scope as it presently exists, in the states with the broadest scope of practice, as well as to create the possibility of growth in ideas, research and treatment opportunities in order to further expand the knowledge and capabilities of our profession. (May 7, 2010)
- The ultimate purpose of [informed consent] is to strengthen our case for defending the treatments that we use, should the need for such a defense ever arise. (November 19, 2010)
- It was unanimously agreed that any research grant money that comes in to NORI should be allocated to our various clinics in proportion to attendance at these board meetings. Those with most consistent attendance would be awarded the most. Those who have only missed one meeting would be eligible for a somewhat lesser amount, two missed meetings, less, etc. (February 18, 2011)
Colleen Huber is also the president of a 501c3 non-profit, charitable organization named the Naturopathic Cancer Society which is run out of her cancer clinic, along with her IRB. The “charity” allegedly raises money for cancer patients who wish to receive but cannot afford alternative treatments, such as those offered by Huber. In fact, Huber’s clinic website solicits donations for their patients in amounts of $1,000, $5,000, and $25,000 and links to the non-profit.
This all seems extremely unethical to me. I said so in no uncertain terms in a blog post I wrote last year titled “Is dubious cancer “doctor” Colleen Huber cybersquatting my name?“.
A friend of the blog, Thomas Mohr, agreed, and I quoted him in that post. He is an oncology researcher at the Medical University of Vienna. He reanalyzed Huber’s data that appeared in her 2014 version of “research” on 317 cancer patients seen over seven years in her clinic. Mohr found that Huber’s data revealed the opposite of what she has been claiming: Huber’s subjects had more than a two-fold higher risk to die under naturopathic care. The odds ratio got exceptionally worse when subjects with incomplete or questionable data were removed from his analysis.
The new cease and desist
In the letter I got from Huber’s German attorney, she takes issue with my cybersquatting post, which I wrote after I discovered that an email address at her Naturopathic Cancer Society (natonco.org) was associated with a website registered in my name (www.brittmariehermes.com) and hosted a “tribute” page to me that also supported naturopathy.
At that time, I hired a lawyer and he emailed a letter to Huber and Hazel Chandler, who was the executive director of the Naturopathic Cancer Society. They never responded. I eventually filed a complaint with ICANN and was able to take control of several domains using variations of my name that I assume were registered by the same person.
Huber’s attorney lays out multiple allegations of defamation, disputing what I wrote in that blog post linked above (quotes below provide more context than what appear in the letter):
- Huber claims she was not cybersquatting. She claims my lawyer did not send a letter.
- Huber claims that her clinic Nature Works Best has not received funds from her charity.
- Huber claims that her research was approved by NORI/IRB in 2010.
- Huber disputes Thomas Mohr’s analysis that I quoted.
- 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.
- Huber and others have not “perhaps found a legal loophole allowing them to blatantly mislead vulnerable cancer patients.”
- Huber is not “As far as I can tell, the ringleader of what appears to be a naturopathic clinical trial and charity hoax.”
Okay. First of all, if the two quotes at the end read funny, that’s because Huber’s lawyer failed to quote my words in entirety, which I have done more so here. In his letter, they were quoted as what appeared to be statements of fact, because the immediate and wider context was omitted. What I wrote in the blog post that offended Huber are my opinions, not statements of fact, plain and simple. Opinions are protected speech and legal.* Second, just like the first cease and desist I got from Bastyr University, this one is outrageous and legally flimsy.
Counterpoints to this legal thuggery
While now I’ve got the domains that were using my name in bad faith, a new one popped up at www.bmdiaries.com.** The site links to Huber’s naturopathic charity and has a similar look and feel to the former websites at the squatted domains.
So, if Nature Works Best is not getting money from patients who received donations from Naturopathic Cancer Society, then where is the money going? Huber’s clinic, IRB, and charity operate at the same address. Huber’s clinic solicits donations for her charity. Huber’s charity promotes Huber’s clinic. Need I say more?
If Huber’s research was approved by her IRB in 2010, why is there no mention of this in the publicly available meeting minutes? Moreover, in 2010, the IRB was not registered with the FDA yet. So any approval by her IRB at that time would have been trivial. Even still, Huber began collecting data for this study in 2006! She repeatedly published her data as a “controlled interventional study.”
Thomas Mohr is a highly qualified medical researcher. Huber is a naturopath who started her research on her cancer patients fresh out of naturopathic school. Huber also dropped out of the Arizona College of Osteopathic Medicine in May 2001 after spending, from what I could tell, 1-1.5 years there.
Huber’s IRB has a boilerplate informed consent form that leaves much to be desired. On the homepage of that IRB’s website it reads, “Upholding the standards of medical freedom and breadth of scope in naturopathic medical practice,” which does not instill confidence that patients’ rights are dutifully protected, first and foremost.
My interpretation of Huber’s naturopathic practice, research, and fund-raising is based on information that she has put out there. In my opinion, Colleen Huber is a cancer quack. What Huber appears to be doing is upsetting. I believe Huber’s research is a sham. I think she may be harming her patients and not aware of it because she appears to be replicating her “research” over and over as if her data is frozen in time in an alternate reality. As far as I can tell, Huber has never reported five-year survival statistics within a rigorously designed research framework.
If you are offended by what Huber is doing, I recommend that you don’t just take my word for it. Look at her website. Look at her charity. Look at her IRB. Read her research. If you think there’s something troubling going on, you can file complaints to any or all of the following organizations:
Office for Human Research Protections
Better Business Bureau – I also want to add that in January 2016 the National Advertising Division (NAD) found Huber’s clinic has troublesome advertising:
[The clinic’s] claims promise cancer patients that they may become healthy, strong cancer survivors in remission if they engage in a course of alternative cancer treatment that includes intravenous vitamin therapy and dietary changes. NAD was concerned that the claims give consumers a reason to believe that the claimed benefits have been proven by rigorous and reliable scientific study.
They referred the matter to the FTC after Huber did not participate in NAD’s voluntary self-evaluation process. The FTC looked the other way. I find it odd that Nature Works Best Cancer Clinic continues to have an A+ rating by the BBB despite NAD’s complaint, among other issues.
Lastly, you can watch the video below to learn more about how she “treats” cancer, why the medical community “has not paid attention to her research,” and how patients appear to be very much so misinformed. I love the line around 8:49 where she says the body has a “congenital need for nutrients and good food,” but then I am horrified that she suggests cancer patients don’t need conventional medicines.
*My German lawyer suggested I shouldn’t leave the reader hanging and should comment on his and my opinion.
**Some commenters online may have noticed that brittmariehermes.com and the other domains that were used in bad faith are currently registered with a third-party in Florida. This was the result of a good samaritan who was able to purchase the domains on my behalf while they were temporarily on embargo after being released by whomever *cough* had them in the first place.
UPDATE (10 September 2017): Additional discussions about Colleen Huber’s research and treatments in the context of the cease and desist letter can be found at Science-Based Medicine and Respectful Insolence.