Archive for Herbs & Supplements

Australian review finds no benefit to 17 natural therapies


Health care systems around the world are being pressured to “do more and spend less”, to make healthcare more cost effective. Owing to aging populations and the growing cost of providing health services, there’s more scrutiny than ever on the value of different health treatments, with the goal of reducing the use of treatments that don’t help. The Choosing Wisely initiative was establishing expressly for this purpose. Regrettably, while well-intentioned, Choosing Wisely hasn’t had as much of an effect as you might expect. Medicine can be slow to change, as David Gorski discussed earlier this week. Unless we ruthlessly scrutinize what we do for effectiveness, and are willing to act on what we learn, self-driven change is unlikely. One way that governments (and insurers) can dramatically reduce the use of a health service or treatment is to simply stop offering it, or paying for it. Yet stopping funding is something that is relatively uncommon in health care. It seems to be much more difficult to stop a practice, possibly owing to inertia, a reluctance to change, and the sometimes-vociferous protests that can emerge from patients or physicians that may feel that their preferred therapy is effective. The formidable challenge of stopping health care funding, once it has started, is one reason why this blog has been very critical of the expanding scope of practice being granted to alternative medicine purveyors – the legislative alchemy that is the first step towards insurance coverage. Because once that’s in place, it will be far more difficult to stop it. So it’s essential to understand the evidence. (more…)

Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Naturopathy, Traditional Chinese Medicine

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US Department of Justice Goes After Supplements

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.

Now the US Department of Justice (DOJ) is getting in on the fun:

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.

This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.


Posted in: Herbs & Supplements, Legal

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Everything you always wanted to know about fermented foods 

Delicious homemade Kimchi (fermented cabbage). It's alive!

Delicious homemade Kimchi (fermented cabbage). It’s alive! Click for a closer look.

Fermented foods, such as sauerkraut and kombucha, have become popular for health reasons. I have made my own sauerkraut in the past and have recently made the tasty, fermented Korean side dish, kimchi. I did it not only for the taste but also for the hope that the bacteria responsible for the fermentation of the cabbage — lactic acid bacteria (LAB) — would contribute to the diversity of my gut microbiota.

As a research scientist in the field of bacterial pathogenesis, this made sense to me. Now that I have started blogging about health and fitness and have been writing more in depth articles about health related topics, I started wondering what research has been done on the health benefits of fermented foods. Can the bacteria in fermented foods even survive the harsh conditions of the human gastrointestinal (GI) tract, particularly the stomach?

I was amazed to learn that the fermentation of food has been used by humans for thousands of years as a way to preserve foods, and that the health benefits go beyond their microorganisms (don’t worry, citations are provided below). The fermentation process enhances the nutritional quality of food by contributing beneficial compounds such as vitamins, and by increasing the bioavailability of minerals. Probiotics, including those found in kimchi, have a range of positive effects on health, including the improvement of various intestinal inflammatory conditions, positive impacts on the immune system and even weight loss, and can alter the composition of the gut microbiome.

However, these effects mostly depend on whether the bacteria actually make it in sufficient numbers to the colon. And let me tell you, the journey to the colon is one harsh and dangerous ride!


Posted in: Herbs & Supplements, Nutrition, Science and Medicine

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“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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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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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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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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Seneff Claims GMOs Cause Concussions

Concussion small
You read that headline correctly.

Stephanie Seneff first came to skeptical attention when she published a study claiming that vaccines were linked to autism. She trolled through the VAERS database and, as David Gorski noted, “tortured the data until it confessed.” Last year she published a paper in which she claimed glyphosate caused autism, claims which I addressed almost a year ago. Gorski also deconstructed this paper, noting, “In fact, if you look at the slides for Seneff’s talks (e.g., this one, available at her MIT web page), you’ll find a tour de force of confusing correlation with causation…”

Seneff is a computer scientist who apparently is anti-vaccine and anti-GMO. In a stunning example of the Dunning-Kruger effect, she feels she can take her computer expertise and export it to biology. She nicely demonstrates that expertise is not so easily transferable.

From autism to concussions

Last year she also published a paper, which escaped my attention until it was recently pointed out to me, claiming that glyphosate, GMOs, and other modern lifestyle factors are responsible for the recent increase in concussions. Her co-author on the paper is Wendy Morely, who is a “Registered Holistic Nutritionist” specializing in the nutrition of concussion. Neither author has any neuroscience background.


Posted in: Genetically modified organisms (GMOs), Herbs & Supplements, Neuroscience/Mental Health

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Here be Dragons: Caring for Children in a Dangerous Sea of sCAM

Here be dragons large map

As a pediatrician working in a relatively sCAM-inclined region, it is not uncommon to find myself taking care of patients who are also being followed by so-called alternative medicine practitioners. This often creates a major obstacle to providing appropriate care and establishing an atmosphere of mutual trust in the provider-patient/parent relationship. It usually makes me feel like I’m battling invisible serpents in a sea of sCAM.

While these double-dipping parents utilize a variety of sCAM providers, including naturopaths, homeopaths, chiropractors, and a smattering of “holistic healers”, most are taking their children to one of a few “wellness” centers near my practice where they are seen by actual medical doctors practicing so-called “integrative medicine”. Many of these children have vague, chronic, usually non-specific complaints that are difficult to explain and thus to treat. Some have behavioral and mental health problems, or neurodevelopmental conditions such as autism for which parents are seeking explanations and treatments.

What I find to be a common theme with these patients is that they and their parents are summarily taken advantage of by their alternative care providers when they are given a fictitious diagnosis and treated with a variety of useless potions, elixers, and false hopes. Often, parents bring their children to these providers because they are frustrated by their child’s chronic complaints of fatigue, pain, or other somatic issues that have eluded a satisfactory diagnosis or treatment. Invariably, the diagnosis that has remained so elusive to me is quickly found and treated by these much more “holistic” and open-minded providers. In fact, I have never seen a consultation note from one of these providers indicating any uncertainty as to diagnosis or treatment regimen. Typically a large battery of expensive, inappropriate, and sometimes outright fraudulent lab tests is ordered, often from equally questionable laboratories. Again, there are invariably interesting findings prompting tailored and bizarre treatments. In typical red-flag sCAM fashion, some of these providers have their own supplement store, available online only to their patients, prominently displayed on their website. These providers are perceived as being more holistically informed about health and wellness then “conventional” doctors like myself, as if there are two distinct ways of treating illness and maintaining health…as if there is truly such a thing as alternative medicine.

It can be very difficult to manage patients who are being simultaneously “treated” by such providers. Sometimes the treatments complicate or confuse the picture, but it always indicates a failure of trust in the “conventional” method of practice, which is science and evidence based, and in science itself.

Below are a few examples of patients cared for by my practice and simultaneously followed by alternative medicine practitioners. They provide a good picture of just how problematic these co-practitioners can be. No names or identifying information are revealed. (more…)

Posted in: Diagnostic tests & procedures, Herbs & Supplements, Naturopathy, Pharmaceuticals, Science and Medicine

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