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On January 1, 2018, the California Naturopathic Doctors Act will be automatically repealed unless the California Legislature deletes or extends that date during the 2017 legislative session, which convenes on December 5, 2016. In addition, according to California law, the Naturopathic Medicine Committee of the Osteopathic Medical Board of California, which regulates naturopathic doctors (NDs), is subject to review by “appropriate policy committees of the Legislature” in the upcoming session.
The California Legislature should not extend the date of the Naturopathic Practice Act. Currently licensed naturopathic doctors could be allowed to continue their practices under a substantially revised practice act but no new licenses should be issued. Frankly, I do not think naturopaths, whether they claim they are “doctors” or not, should be allowed to practice at all. However, the political realities of getting a bill passed completely doing away with the practice of naturopathy may require some accommodation to currently licensed NDs. (more…)
In 2009 CCSVI was proposed by Italian vascular surgeon, Dr. Paolo Zamboni – that multiple sclerosis (MS) is caused by chronic blockage of the veins that drain the brain. Since that time we have seen the evolution of a medical pseudoscience. It has been a fascinating case study in how science sorts out what works and what doesn’t, and how patients, believers, and the public react to this information. The story is ongoing and there are some interesting updates.
Background on CCSVI
CCSVI stands for chronic cerebrospinal venous insufficiency. Zamboni believes that blockages in the veins that drain blood from the brain cause back pressure in the brain, decreasing blood flow and leading to secondary inflammation, and further that this results in the clinical diseases we collectively known as MS. Zamboni’s interest in MS is not random. His wife has MS, and it is interesting that he is a vascular surgeon and found what he believes is a cause of MS that can be treated by vascular surgeons. This does not mean his ideas are wrong, it just means he has a clear bias and his data needs to be looked at carefully and independently replicated.
His initial study found that 100% of the patients he examined with MS had cranial venous blockage. That is also curious. We rarely find 100% correlations in medicine, even for solid theories. It is a huge red flag for systematic bias.
The MS community was appropriately skeptical. While the exact cause of MS remains unknown, we have been studying it for decades and there is a lot we do know. We know, for example, that MS is primarily an autoimmune disease, and the pathology is largely caused by inflammation. We now, in fact, have a long list of effective treatments for some types of MS that suppress the immune system and inflammation. There are still some types, such as chronic progressive MS, that do not respond to the best treatments.
The idea that MS was caused by vascular blockage was therefore a radical idea that flew in the face of existing research. Occasionally, however, radical ideas turn out to be true, and so some MS researchers set out to test Zamboni’s hypothesis.
Over a year ago I wrote about escharotic treatments for cervical dysplasia. It is offered not by MD gynecologists but by chiropractors and naturopaths, along with inconsistent and unproven diet recommendations and supplements. A corrosive agent similar to “black salve” is applied repeatedly to the cervix; it works by destroying tissue. There are no controlled studies evaluating it for safety and effectiveness. One major drawback is that there is no surgical specimen to submit to pathology to determine if there is invasive cancer. I urge you to read my first article for further details. Escharotic treatment is decidedly not a good idea.
In that article I focused on the treatment itself. I recently revisited the website of the chiropractor I mentioned in that article, Nick LeRoy, and I want to comment on some other issues raised by this individual who is offering the treatment.
Who is Nick LeRoy?
On one website he is listed as a Chicago holistic medicine physician and primary care physician for an HMO, Alternative Medicine Incorporated, which he says is underwritten by Blue Cross/Blue Shield. When I googled for Alternative Medicine Incorporated, I found a company in England, but none in America with that name. On his other website he claims to have “post-doctoral medical training in gynecology and internal medicine and to be a credentialed primary care physician (PCP) for Blue Cross of IL.” I phoned Blue Cross of Illinois, and they told me he was not listed as a provider in their records. They suggested I contact him directly to ask for clarification. I did, by email. He didn’t answer.
He has taken courses in acupuncture and Traditional Chinese Medicine, and got “private breast thermography training.” It’s not clear how much training he has in gynecology. On one page of his website he says his “integrative medicine training included gynecology, internal medicine, acupuncture, chiropractic, and nutrition.” In a video, he says he has been specializing in gastrointestinal disorders for twenty years, and he describes how he does unconventional food allergy testing for 154 different foods.
He lists himself as “DC, MS, AcT,” but he calls himself “doctor” and readers are likely to assume he is an MD. The testimonials all refer to “Dr. LeRoy.” He sells his books and supplements through his “doctor’s supplement store.” (more…)
German alternative cancer clinics: Combining experimental therapeutics with rank quackery and charging big bucks for it
A couple of months ago, I discussed patient deaths at an alternative medicine clinic in Europe, where a naturopath named Klaus Ross had been administering an experimental cancer drug (3-bromopyruvate, or 3-BP) to patients outside the auspices of a clinical trial. 3-BP is a drug that targets the Warburg effect, a characteristic of cancer cells first reported in the 1920s by Otto Warburg in which the cancer cell changes its metabolism to shut off oxidative phosphorylation (the part of glucose metabolism requiring oxygen that produces the most energy) to rely almost exclusively on glycolysis and anaerobic metabolism. From a cancer cell evolution standpoint, one can understand why cancer cells would behave this way, as this change allows them to survive in environments with much less oxygen than normal cells, but the side effect of the Warburg effect is that cancer cells consume a lot of glucose for their energy needs. Indeed, positron emission tomography (PET scanning) takes advantage of this characteristic of cancer cells to use glucose labeled with a positron-emitting isotope that accumulates in cells. The result is that cancer cells, which in general use a lot more glucose than normal cells, light up compared to the surrounding tissue, allowing the identification of areas suspicious for cancer. Targeting the Warburg effect is therefore a strategy to attack cancer cells preferentially.
Since I wrote about the tragic deaths of those cancer patients, I’ve been seeing stories about German alternative medicine cancer clinics popping up in my newsfeed over and over again. Intuitively, you’d think that a scientifically advanced economic powerhouse like Germany would have stricter regulations over the practice of medicine, but, the more I looked into these clinics, the more I realized that there are a lot of quack clinics in Germany every bit as quacky as any clinic in Tijuana, but with a twist. Like Mexican alternative medicine clinics, German clinics often charge enormous sums of money for treatments that range from the unproven to the dubious to pure quackery. However, in addition to the rank quackery, German cancer clinics include legitimate experimental drugs that are as yet unproven and might even only have cell culture or animal evidence supporting its potential efficacy. Indeed, 3-BP is just such an example. It is a legitimate candidate cancer drug that’s in the pipeline, having shown promise in cell culture and animal experiments, but that has no human data from systematic clinical trials yet, just a handful of anecdotes when it was tried in humans under desperate circumstances. Not surprisingly, Klaus Ross’ main clinic is in Germany, and, like so many other clinics there, he was administering an as-yet-unapproved drug to humans.
So, prodded by a couple of recent stories from the UK, I decided to take another look at these German cancer clinics.
Steven Novella recently wrote a post discussing an FDA warning against the use of homeopathic teething products over safety concerns related to the possibility of toxic amounts of belladonna. He goes into the hypocrisy of the FDA regulation of homeopathic products, a topic covered numerous times here on Science-Based Medicine, as well as the misleading initial response from Hyland’s, producers of the most popular homeopathic teething remedies in the United States and Canada. There have been some updates over the past two weeks that I’ll cover in this post. (more…)
Natural Health Products: Loosely regulated, little evidence of benefit, and an industry intent on preserving the status quo
This week’s post will revisit a topic I recently covered, but it’s time-sensitive and needs your input. Health Canada, the Canadian equivalent to the US Food and Drugs Administration, is considering revisions to the way in which it regulates dietary supplements, which are called “natural health products” in Canada. It is rare that a regulator acknowledges that a regulatory system isn’t working, and publicly expresses a commitment to being more science-based. There is a time-limited opportunity for the public (including all of you non-Canadians!) to provide comment on how supplement regulation could be more closely aligned around scientific principles, rather than the supplement industry’s priorities. Whether you take dietary supplements or not, we can probably all agree that consumers should have access to safe products as well as credible, relevant information about these products, in order to make informed health decisions. It will likely not surprise you that these ideas are seen as threats to supplement manufacturers, who benefit from little regulatory oversight and few restrictions on what can currently be claimed about any product’s effectiveness. Since my last post, there have been some new reactions to the consultation that are worth discussing. (more…)
There is an ongoing debate that has come to the fore recently about the ultimate limits of human longevity. The ultimate goal of medicine is to optimize health, with the result of maximizing the duration and quality of life. This is accomplished through health promotion, disease prevention, and disease treatment.
There is no question that this approach has increased life expectancy, which is the number of years one can statistically expect to live. The longevity debate is about life span – how long could a human theoretically live if they enjoyed optimal health? What is the ultimate limit of the human biological system?
A recent study by Dong, Milholland, and Vijg concludes that we are already reaching the maximal human lifespan, which they calculate at about 115 years. They looked at two statistical trends. First they looked at the age of the oldest person to die in each country, and found that this age increased from 1970 to 2000, reaching an average of about 115 years. From 2000 to present, however, this figure has peaked, and in fact trended down slightly.
They also looked at the age that had the greatest annual increase in survival. If both life expectancy and lifespan were increasing then this number should be increasing. They found that this number was also increasing from 1920 to about 1980, but then plateaued at around 100 years, and has only slightly crept up since then (101 for men, 102 for women).
Dr. Richard Rawlins, an orthopedic surgeon in the UK who is also a magician and member of the Magic Circle, has written an exhaustive review of alternative medicine, Real Secrets of Alternative Medicine: An Exposé.
“A conversation with Mrs. Smith”
A conversation with Mrs. Smith bookends the text. She comes to Dr. Rawlins for hip replacement surgery and asks if there is any alternative medicine she could try first. He tells her some patients say they have benefited, but personal experience is no substitute for critical analysis of evidence. He explains that there is no evidence to support those alternatives but that if she wants to try them, she can go ahead and try. Then she asks which one is most likely to help her. He tells her he can’t recommend one because he has not studied them in any detail. She says perhaps he should study them, and then write a book. So he does.
At the end of the book, he tells Mrs. Smith what he has learned: that complementary and alternative medicine (CAM) “works” but only as a placebo; it does not affect disease outcomes and can sometimes do harm. He quotes cancer researcher David Grimes:
By clinging to delusion, belief in alternative medicine denigrates the very wonder of science and medicine and the massive strides we as a species have made over the last century or so in understanding the world around us, and how our bodies work.
Rawlins ends the book by telling Mrs. Smith “Conventional practitioners care more than you may think. That is the real secret.”
In between those conversations is a 370-page tour de force that covers the entire history of medicine and CAM, stresses the importance of scientific evidence, reviews how good the brain is at deluding itself, explains the placebo effect and the attractions of CAM, and argues that society should not pay for it. (more…)
[Editor Note: This is a greatly expanded version of my initial thoughts on a study about mammography published in the New England Journal of Medicine last week on my not-so-super-secret other blog. It’s such an important topic that I thought SBM should see my discussion too, and I couldn’t just cut and paste it. You deserve original material.]
I knew it. I just knew it. I knew I couldn’t get through October, a.k.a. Breast Cancer Awareness Month, without a controversial mammography study to sink my teeth into. And I didn’t. I suppose I should just be used to this now. I’m referring to the latest opus from H. Gilbert Welch and colleagues that appeared in the New England Journal of Medicine last week, “Breast-Cancer Tumor Size, Overdiagnosis, and Mammography Screening Effectiveness.” Yes, it’s about overdiagnosis, something I’ve blogged about more times than I can remember now, but it’s actually a rather interesting take on the issue.
Before 2008 or so, I never gave that much thought to the utility of mammographic screening as a means of early detection of breast cancer and—more or less—accepted the paradigm that early detection was always a good thing. Don’t get me wrong. I knew that the story was more complicated than that, but not so much more complicated that I had any significant doubts about the overall paradigm. Then, in 2009, the United States Preventative Services Task Force (USPSTF) dropped a bombshell with its recommendation that mammographic screening beginning at age 50 rather than age 40 for women at average risk of breast cancer. Ever since then, there have been a number of studies that have led to a major rethinking of screening, in particular screening mammography and PSA testing for prostate cancer. It’s a rethinking that affects discussions even up to today, with advocates of screening arguing that critics of screening are killing patients and skeptics of screening terming it useless. Depending on the disease being screened for, the answer usually lies somewhere in between. Basically, screening is not the panacea that we had once hoped for, and the main reason is the phenomenon of overdiagnosis. Before I go on, though, remember that we are talking about screening asymptomatic populations. If a woman has symptoms or a palpable lump, none of this discussion applies. That woman should undergo mammography.