“Safe” dietary supplements can land you in the emergency room

Dietary supplements
If there’s one thing I’ve been consistent about, it’s that, however ridiculous all the other woo I routinely discuss here is—homeopathy, reiki, reflexology, I’m talking to you and your friends—herbal medicine and supplements might have value because they might have a physiological effect that is beneficial in treating or preventing disease. Of course, if that’s the case, it’s because the herb or supplement contains chemicals that act as drugs. They’re “dirty” drugs in that they are mixed with all sorts of other substances in the herb or supplement that might or might not have effects, which means that different lots of the herbs or supplements often have different activity, but they are drugs nonetheless. That’s why, for instance, doctors don’t tell patients to chew on foxglove leaves when they want a patient to get digoxin. Digoxin is a powerful drug with a relatively narrow “therapeutic window,” meaning that the difference between the levels of the drug in the blood needed for therapeutic effect are not very far from toxic levels; so predictable, reliable drug content is essential. I just learned a while ago that within the living memory of some older physicians digoxin actually was prescribed as crude extracts, which was very difficult and dangerous, hence the necessity of purification. In other cases, (such as Artemisinin, for which Youyou Tu was recently awarded the Nobel Prize in Physiology or Medicine), crude plant extracts do not contain sufficient quantities of the active component, necessitating its isolation, purification, and, in some cases, chemical modification to increase its absorption, stability, or activity.

One thing that proponents of herbal medicine and supplements often forget, though, is that if herbs or supplements can have potentially beneficial effects (albeit difficult to regulate effects due to the crude, impure nature of the extracts often used) because they contain drugs, then herbs and supplements can also produce adverse events, again, because they contain drugs. You can overdose on herbs and supplements. This point was recently reinforced by a new study by Geller et al. published last week in the New England Journal of Medicine (NEJM), entitled “Emergency Department Visits for Adverse Events Related to Dietary Supplements.” It was carried out by investigators from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, and Chenega Government Consulting; and the Center for Food Safety and Applied Nutrition and the Division of Public Health Informatics and Analytics and the Division of Dietary Supplement Programs, Food and Drug Administration. The title pretty much tells you what the study is about, and what the study is about is that dietary supplements cause a lot of visits to the emergency room every year; 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year can be attributed to adverse events related to dietary supplements.

Posted in: Herbs & Supplements, Politics and Regulation

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A liquid that was almost, but not quite, entirely unlike tea.

A coffee enema - almost, but not quite, totally unlike tea.

A coffee enema – almost, but not quite, totally unlike tea…and some sort of complex analogy involving naturopathy and science.

Those of you in the know recognize the title from the Hitchhikers Guide to the Galaxy, among the funniest and most quotable books of all time. If you have not read the five books in the trilogy, get to work. Consider it a homework assignment.

I bit off more than I can chew for this entry. I usually plan on about 8–10 hours over 4 –5 days to write these entries. So I had this idea. Now that naturopaths have been declared primary care providers by the Oregon legislature I thought it would be good to look over all the websites in Portland to see, in their own words, what naturopaths were offering. I figured there would not be that many sites to review. How many naturopaths could be in Portland?

So I went to the Oregon Board of Naturopathic Medicine Licensee Directory and entered Portland into the search box. And?

578 hits.

There is not enough beer time in the world

Holy Cannoli. I thought there would be 30, which is the number infesting Eugene, the second most naturopathed city in Oregon. There is no way that I could do a comprehensive review of that many websites in the limited time I have to devote to the blog. But my brain is not unlike an oil tanker with blog entries, it takes a long time to change direction and I had nothing else mentally lined up to write about. (more…)

Posted in: Naturopathy

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The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements

Screenshot 2015-10-14 23.04.19

A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the United States Court of Appeal for the Second Circuit, which covers Connecticut, New York and Vermont.

For this reason, the case, Amarin Pharma, Inc. v. FDA (Amarin), received a good deal of attention in the world of drug regulation. (Here is an excellent analysis by two attorneys who practice in the area of drug regulation.) First, we’ll take a look at the issue of off-label promotion. Then we’ll look at an issue that really didn’t engender much comment, but that I find fascinating: how the same substance can be subject to very different regulatory treatment, depending on whether it is sold as a dietary supplement or prescription drug.

Background: Initial approval of Vascepa and subsequent research

In 2012, the pharmaceutical manufacturer Amarin received FDA approval for a new drug, Vascepa, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides ≥ 500mg/dL). Approval was based on a single phase 3 clinical trial.

Following that approval, Amarin designed a second single phase 3 clinical trial to look at the effect of Vascepa on triglyceride levels among statin-treated patients with persistently high triglycerides (≥ 200 and ≤ 500 mg/dL). Pursuant to an agreement with the FDA that, if it met certain conditions, Vascepa would obtain approval for this use, Amarin proceeded with an FDA-approved protocol. As a further condition of the agreement, it also began enrolling patients in a third trial to see if Vascepa actually reduced major cardiac events. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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Whole Body Vibration Therapy

WBVTWhen skeptics hear the term “vibration” a red flag goes up, because that is a common term used in pseudoscientific jargon. Vibrations are often used to refer vaguely to energy or some physical or even spiritual property that cannot be detected, and is used in a hand-waving manner to explain extraordinary claims.

Vibrations, however, are also a real thing, referring to physical oscillations. Whole body vibration therapy (WBVT) refers to these legitimate physical vibrations. It is being offered as a treatment for balance, back pain, neurological disorders, and also simple fitness. Does it actually work, however, for the indications claimed?

What is WBVT?

WBVT is considered a passive exercise modality, in which something is being done to the person, rather than the person actively engaging in an activity, such as walking, weight lifting, or swimming. With WBVT users lay, sit, or stand on a platform that vibrates rapidly in one or more directions. The idea is that the rapid vibrations force the muscles of the body to contract in reaction, providing a form of exercise.


Posted in: Neuroscience/Mental Health

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Weston Price’s Appalling Legacy

Weston A. Price Foundation: Not recommended

Weston A. Price Foundation: Not recommended

One of our readers requested a post about the Weston A. Price Foundation (WAPF). I knew it was not a trustworthy source of medical information, but I had not imagined just how atrocious it really was. After spending some time on the website, I realized that it is not just a cornucopia of false information about dentistry and nutrition, but is full of anti-vaccine propaganda and bizarre and dangerous health advice that could result in serious harm to patients.

The purpose of the Weston A. Price Foundation

It is a non-profit, tax-exempt charity founded in 1999 to disseminate the research of Weston A. Price, who “established the parameters of human health and determined the optimum characteristics of human diets.” (He did no such thing!) It publishes a journal “dedicated to exploring the scientific validation of dietary, agricultural and medical traditions through the world.” That statement reveals how poorly they understand science. The purpose of science is not to “validate” traditions and beliefs; it is to ask “if” those traditions offer any demonstrable benefits, and if the beliefs correspond to reality. (more…)

Posted in: Dentistry, Nutrition, Vaccines

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Sarah Hershberger: “Health freedom” and parental rights vs. child welfare

Sarah Hershberger, pictured with her family in a 2014 video.

Sarah Hershberger, pictured with her family in a screenshot from a 2014 video.

One of the more depressing topics that I regularly write about on this blog includes of analyses of news stories of children with cancer whose parents decided to stop science-based treatment (usually the chemotherapy) and use quackery instead. There are, of course, variations on this theme, but these stories take form that generally resembles this outline: A child is diagnosed with a highly treatable cancer with an excellent cure rate. Standard science-based treatment is begun, but the child suffers severe side effects from the chemotherapy. After an incomplete course of chemotherapy, the parents, alarmed at their child’s suffering, start balking at further chemotherapy, either because the child refuses further treatment or because they do. At some point in this process the parents become aware of the claims of practitioners of this or that alternative medicine, who tell them that their child’s cancer can be cured without toxic chemotherapy, and, wooed by the siren song of a promise of a cure without suffering, the parents choose that instead. At this point, physicians, alarmed at the parents’ choice, call in their state’s child protective services team, and a court battle ensues. Sometimes the court battle results in an order that the child complete conventional therapy, as it did with, for example, Daniel Hauser or Cassandra Callender. Sometimes it ends with a compromise in which the child and/or parents can choose an unconventional practitioner, as in the case of Abraham Cherrix. All too often the courts utterly fail to protect children with cancer, as the Canadian courts did in the cases of Makayla Sault and JJ. Not infrequently, if the court rules against the parents, the parents flee with their child to avoid treatment, as happened with Daniel Hauser, Abraham Cherrix, and Sarah Hershberger. Usually, they ultimately come back.

However they turn out, over the years of looking into them I’ve found that these stories tend to bear a depressing similarity and predictability. For example, if the child does well, it is always attributed to the alternative treatment, even when the child received a significant amount of conventional therapy. This attribution derives from a fundamental misunderstanding of how the treatment of cancer works in that the problem with incomplete cancer treatment is not that it can’t cure the cancer but that it has less of a chance of doing so. As I’ve explained many times, the reason that treatment regimens for many pediatric cancers involve two years’ worth of chemotherapy is that over time pediatric oncologists learned the hard way that, although the first cycle of chemotherapy (usually called induction chemotherapy) can lead to remission, without the additional cycles the chances of recurrence are very high—unacceptably so. Consequently, children who stop chemotherapy early can be in remission; they’ve just been put at a high risk of recurrence.

Posted in: Cancer, Herbs & Supplements, Naturopathy, Politics and Regulation

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Presidential candidate Ben Carson: Shilling for Mannatech with his very own alternative cancer cure testimonial?

Ben Carson fires up the Mannatech faithful by telling them how it helped him cure his prostate cancer. Well, that and the nerve-sparing prostatectomy he underwent and the fact that the spine lesions he thought to be metastases were really not metastases at all.

Ben Carson fires up the Mannatech faithful by telling them how it helped him cure his prostate cancer. Well, that and the nerve-sparing prostatectomy he underwent and the fact that the spine lesions he thought to be metastases were really not metastases at all.

Over the years, mainly at my not-so-super-secret other blog, I’ve frequently made the points that the vast majority of physicians are not scientists and, in fact, that many of them suffer from a severe case of Dunning-Kruger when it comes to science outside of biomedical sciences—or even biomedical sciences outside of their medical field of expertise. The most common science I’ve seen physicians embarrass themselves attacking has generally been evolution, with a disturbingly high number of physicians denying evolution and embracing creationism. Of these, the doctor I wrote about most frequently back in the day was the creationist neurosurgeon Michael Egnor, but with the onset of the 2016 Presidential race there’s been a new creationist neurosurgeon in town with arguably even more ignorant attacks on evolution. I’m referring, of course, to noted neurosurgeon Ben Carson, whose creationist stylings have been so bad that I had to use him as a poster child to demonstrate how the vast majority of physicians are not scientists and all too many of us have an inordinate and unjustified confidence in medicine as a “check on BS.”

Over the last couple of weeks since my post on the second Republican debate, in which Donald Trump spewed antivaccine nonsense and Ben Carson pandered to antivaccine views, even though past statements by him demonstrate that he knows better, unfortunately Carson has continued to spew statements that are nothing but downright embarrassing, be they his statement in the wake of the Oregon mass shooting that it would be better to attack an armed gunman during a mass shooting “because he can’t get us all” (complete with a seeming attitude that those who died were cowardly), his doubling down on that by claiming that if the Jews had been armed maybe things would have turned out differently in the Holocaust (neglecting the fact that Jews did resist), or his many other statements that make me wonder how someone with so little critical thinking skills could get through medical school and a neurosurgery residency to become such a respected surgeon.

Posted in: Cancer, Herbs & Supplements, Nutrition, Politics and Regulation

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“Magic Socks?” Alternative Medicine’s Obsession With Your Feet.


Inappropriate earthing technique?

I recently received an email from none other than Jann Bellamy pointing out a particular flavor of naturopathic nonsense that I had missed up until this point: “magic socks.” A quick search revealed that our own Scott Gavura had briefly mentioned this remedy in a 2013 post, but I plan on going into much greater detail. The claim contained in the newsletter attached to Jann’s email involved the use of said magic socks to “alleviate congestion.” Three links were thoughtfully provided for more information and I took the bait. Thanks Jann.

That’s right, magic socks!

The first link took me to the website of Bastyr University, where Britt Hermes matriculated to the tune of $300,000 and a leader in “innovation in natural health education” that offers numerous degrees in “science-based natural medicine.” According to the experts at Bastyr, wet sock treatment, apparently synonymous with “magic socks”, is “a natural method of stimulating the immune system and zapping a cold or flu” that involves forcing a child to don ice-cold socks overnight. They even admit that this is a treatment approach recommended regularly by the naturopathic physicians at Bastyr Center for Natural Health.

According to the chief medical officer at BCNH (seems like there should be an asterisk there or something), we shouldn’t be thrown by how much this sounds like complete and utter nonsense, because it works. He reassures us that magic socks “rally the body’s defenses” using the healing power of nature. And it’s free! All you need is water, socks, a freezer, and some electricity. Okay, so it isn’t free but it’s pretty darn cheap. (more…)

Posted in: Naturopathy, Science and Medicine

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No, the Nobel Prize does not validate naturopathy or herbalism

Herbal medicine
The 2015 Nobel Prize in Physiology or Medicine was awarded Monday, acknowledging the developers behind two drugs used to treat parasite infections. In a shared award, William C. Campbell and Satoshi Ōmura won for the discovery of avermectin, and Youyou Tu won for the discovery of artemisinin. Given both of these products are derived from natural substances, and “natural” remedies are used in different alternative medicine philosophies, it is perhaps not surprising that advocates claimed that this somehow validates practices like Traditional Chinese Medicine (TCM) and naturopathy. The Association of Accredited Naturopathic Medical Colleges (AANMC) made the following announcement on their Facebook page:
aanmc announcement
Which if you follow the link to the CNN story and actually read it, is surprising. It doesn’t mention naturopathy at all. In fact, when you look closer at the two drugs and their development, this year’s Nobel Prize is actually an excellent case study that illustrates the inherent limitations and weaknesses in alternative medicine systems like naturopathy, herbalism or TCM, while reinforcing just what science-based medicine is capable of delivering. (more…)

Posted in: Basic Science, Herbs & Supplements, Naturopathy

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Tobinick Lawsuit Update – Justice Has Prevailed


On September 30, the U.S. District Court for the Southern District of Florida granted Dr. Novella’s motion for summary judgment, ending the lawsuit against him by Dr. Edward Tobinick and two of his companies. Earlier in the case, all of the other defendants had filed successful motions to dismiss or for summary judgment and were no longer parties to the case.

That he won the remaining issues in the case on a motion for summary judgment is highly significant. Summary judgment motions are granted sparingly by the courts. In granting his motion, the judge was required by law to view the facts in the light most favorable to Tobinick and the other plaintiffs and draw all reasonable inferences from those facts in their favor.  Dr. Novella had to convince the judge that there was no dispute as to any of the relevant facts and that those undisputed facts entitled him to prevail. Because of this ruling, the case will not go to trial.

For a quick background, Tobinick filed a suit against Dr. Novella, the Society for Science-Based Medicine (SFSBM), Yale University and SGU Productions. The subject of his suit was an article Dr. Novella wrote here critical of his claims that perispinal etanercept can treat a variety of neurological conditions, as well as a second article, posted after suit was filed.


Posted in: Announcements, Science and Medicine

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