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Kratom: another dangerous “natural” remedy

Mitragyna_speciosa111
Kratom (Mitragyna speciose) is a tropical tree from Southeast Asia whose leaves are traditionally chewed or prepared as a powder. Native populations chew the leaves to reduce fatigue when doing manual labor, such as working on rubber plantations. It is also used in cultural performances and consumed as a drink prepared from kratom powder. When the Second World War caused an increase in the price of opium, Thai addicts forced to cut back on opium consumption used kratom to ease their withdrawal symptoms. Thailand and other Southeast Asian countries have passed laws controlling its use and other countries have followed suit, including Australia and New Zealand where it is banned.

In the past several years, kratom consumption has spread beyond traditional uses and the confines of Southeast Asia. In the U.S., it is widely available in head shops, kava bars, and on the internet. It is touted as a legal, psychoactive alternative to other sedative and stimulant-type drugs, both legally and illegally obtained. It is marketed for opioid and alcohol withdrawal symptoms, chronic pain and appetite reduction, among other things. There is also anecdotal evidence of naturopaths prescribing it for opioid withdrawal and depression. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Diatomaceous Earth? No Thank You!

Would you eat this? It might look like a crunchy new breakfast cereal, but it's a close-up of diatomaceous earth, the fossilized microscopic skeletons of diatoms.

Would you eat this? It might look like a crunchy new breakfast cereal, but it’s a close-up of diatomaceous earth, the fossilized microscopic skeletons of diatoms.

Diatoms are unicellular algae, one of the two major classes of the phytoplankton that constitute the bottom of the food chain in oceans and freshwater. Diatomaceous earth is a soft, siliceous sedimentary rock containing the fossilized skeletal remains of diatoms. It has been used as a bug killer: it is hypothesized that the sharp particles physically cut up the insects and also damage their waxy protective layer, causing dehydration. It is also used as an abrasive, a filter, an anticaking agent, and in various other industrial and agricultural applications. It contains silica, mainly in the form of amorphous silicon dioxide but with some crystalline silica. Silica is dangerous when inhaled, causing lung disease in workers exposed to silica dust. Silicosis is the most common occupational disease worldwide.

Those are the indisputable facts. So far, so good. Now for the unsupported claims. Diatomaceous earth is being sold as a dietary supplement and is being promoted as “one of the cheapest and most versatile health products on the market.” One of the red flags for quack remedies is the claim that the remedy works for a long list of disparate ailments. Another is that the claims are supported only by testimonials, not by scientific studies. Another is the claim that it “detoxifies.” And most of those who claim it works just happen to have their own brand that they want to sell you. Diatomaceous earth fits the bill, on all counts. But just because it walks like a duck doesn’t mean we can summarily dismiss it. To be fair, we must examine the claims and the evidence. (more…)

Posted in: Herbs & Supplements, Nutrition

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FDA efforts to improve compounded drug safety upsets naturopaths

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Favorite naturopathic treatments comprise pumping patients full of dubious mixtures by injection, including IV drips. Naturopaths also employ topicals (salves, ointments and creams), rectal, and vaginal suppositories, and oral medications, such as bio-identical hormone replacement therapy, all made from “natural” substances.

According to the American Association of Naturopathic Physicians (AANP)

these nutritional, herbal and homeopathic remedies are compounded to meet unique patient needs and are not typically available from the large drug manufacturers that don’t make small batches of such specialized products.

Not to mention the fact that it is highly doubtful these questionable remedies could make it through the FDA drug approval process, which requires proven safety and efficacy.

The FDA’s recent steps to improve drug compounding safety is a welcome curb on these practices. Draft Guidance issued in April addresses both compounding for office use and by prescription. (“Office use” refers to creating a supply of a compounded drug to be used by a health care practitioner as needed, as opposed to compounding a drug per a specific prescription for an individual patient.) In June, the FDA also issued an Interim Policy on substances that can be used in compounding a drug. We’ll discuss how these affect naturopathic practice in a moment. (more…)

Posted in: Guidelines, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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The THRIVE Experience: Masterful Marketing, Short on Substance

One of the few things that aren't in THRIVE products

One of the few things that aren’t in THRIVE products

My daughter told me about the latest health fad among her group of acquaintances. She knows people who are spending $300 a month on the THRIVE program and claiming miraculous results. With a skeptic for a mother, my daughter knew enough to question the claims and do her own research; she was not impressed. She concluded that THRIVE was essentially selling caffeine and vitamins at exorbitant prices.

Claims on the website

THRIVE is offered by Le-Vel Brands, LLC. A slick video on the website asks:

Are you ready to hear about the hottest weight loss, nutrition and fitness plan sweeping North America? It’s called the THRIVE 8-week experience. The only premium lifestyle transformation plan. People from all walks of life are accomplishing their physical goals with THRIVE, and many are also accomplishing their financial goals by choosing to promote the experience.

  • Weight management
  • Joint support
  • Pain management
  • Antioxidant support
  • Cognitive performance
  • Lean muscle support
  • Anti-aging
  • Digestive and immune support
  • Calms general discomfort

“You’re going to live, look, and feel Ultra Premium like never before.”

Testimonials: yes. Hype: yes. Evidence: no. (more…)

Posted in: Herbs & Supplements

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About Herbs: an app to avoid

Pictured: A better source of health information than "About Herbs".

Pictured: A better source of health information than “About Herbs”.

Medicine has an intellectual hierarchy. Supposedly the best and the brightest are in the academic medical centers and are the thought leaders in their field.

Those of us lower in the hierarchy are well aware of some of the warts present on our betters, but I would expect those at the top would adhere to the highest intellectual and ethical standards. People being, well, people, expecting exceptional standards is admittedly an unrealistic expectation.

It would appear that many academic centers are doing their best to avoid meeting my expectations, attempting to abandon all standards.

I mentioned over at SfSBM that Dana-Farber is spending 2 million dollars on a renovation to, in part, offer the unmitigated steer manure that is reiki and reflexology to their cancer patients. Yes. Reiki. Reflexology.

Those are not fracking earthquakes in Kentucky, those tremors are the result of the tremendous kinetic energy of Flexner spinning in his grave as his life’s work becomes a farce.

Dana-Farber is just one of many academic medical centers who are putting their imprimatur on nonsense.

Memorial Sloan Kettering Cancer Integrative has released “About Herbs”, an iPad/iPhone guide to Botanicals, Supplements, Complementary Therapies and More. Spoiler alert: the ‘More’ does not include critical thinking. This guide is not anywhere as ludicrous as offering reeky, sorry, reiki, but at times it comes close. (more…)

Posted in: Acupuncture, Commentary, Critical Thinking, Herbs & Supplements, Homeopathy, Traditional Chinese Medicine

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The rise and inevitable fall of Vitamin D

Is Vitamin D a panacea? The evidence says otherwise.

Is vitamin D a panacea? The evidence says otherwise.

It’s been difficult to avoid the buzz about vitamin D over the past few years. While it has a  long history of use in the medical treatment of osteoporosis, a large number of observational studies have linked low vitamin D levels to a range of illnesses. The hypothesis that there is widespread deficiency in the population has led to interest in measuring vitamin D blood levels. Demand for testing has jumped as many physicians have incorporated testing into routine care. This is not just due to alternative medicine purveyors that promote vitamin D as a panacea. Much of this demand and interest has been driven by health professionals like physicians and pharmacists who have looked at what is often weak, preliminary and sometimes inconclusive data, and concluded that the benefits of vitamin D outweigh the risks. After all, it’s a vitamin, right? How much harm can vitamin D cause? (more…)

Posted in: Herbs & Supplements, Nutrition

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Fooling Myself

They may have different packages, but these products are all the same inside.

Nothing says opportunistic like selling water for pain control.

The first principle is that you must not fool yourself — and you are the easiest person to fool.

Richard Feynman

I like to think of myself as a rational person, but I’ve been fooled by my own experience again and again. I’ve made bad decisions and wasted time and money believing what I was seeing, instead of being objective and looking at the evidence. One of my most memorable lessons has come over the past 14 years with my Labrador Retriever, Casey.

First the personal

We acquired Casey as a puppy, and she was less than a year old when she started limping. Investigations confirmed dysplasia, a genetic condition that leads to degenerative joints, arthritis, and pain. We were devastated. After considering the few treatment options that existed, we decided to skip surgery and treat it conservatively. I had no desire to start her on a lifetime of anti-inflammatory drugs, being very familiar with their side effect profile. I was familiar with a supplement used widely in humans that had some weak but somewhat promising evidence: We started giving her glucosamine and chondroitin supplements regularly. And we watched and waited.

It took some time, but Casey did appear to improve. We were thrilled. Life went on, and other than the occasional rough play session, Casey’s limping was mild, and she thrived. We continued the supplements, confident that we were doing good. But eventually I started paying attention to the emerging evidence on glucosamine and chondroitin. Once touted as a panacea for arthritis and joint pain, there had finally been some high-quality trials conducted – and the results were disappointing. Even this blog covered the issue, and contributors like Harriet were skeptical of glucosamine. Its supposed mechanism of action really wasn’t even that plausible. I started to wonder if the supplements were really doing anything for my dog’s pain. Eventually I decided on a trial – so I stopped the supplements about seven years after I started them. Neither my wife nor I could notice any difference at all in her mobility. Nor did the veterinarian. We’d been fooling ourselves, spending hundreds of dollars in the process. (more…)

Posted in: Critical Thinking, Herbs & Supplements, Science and Medicine

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Supplements, Lies, and a Lengthy Transcript

Thanks, Congress, for making bull testicles available as a dietary supplement!

Thanks, Congress, for making bull testicles available as a dietary supplement!

On October 21, 1993, there was a hearing before the U.S. Senate Committee for Labor and Human Resources, with the long-winded title:

Examining How the Federal Government Should Regulate the Marketing and Use of Dietary Supplements and Related Measures, Including S. 784, To Strengthen Federal Standards with Respect To Dietary Supplements.

S. 784, sponsored by Sen. Orrin Hatch, would eventually be enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA).

I discovered this bit of Congressional theater when doing research for my recent talk at NECSS. Scott Gavura and I joined forces to present “Natural Disaster: Dietary Supplements.” Scott focused on pharmacology, while I talked about FDA regulation of dietary supplements (or lack thereof). Thanks to him, I now have a rudimentary knowledge of pharmacokinetics, the science behind how a drug or supplement works (or doesn’t) in the body. If you haven’t read his post from last week explaining this, and more, you should.

Reading the lengthy hearing transcript (well, ok, a lot of it) confirmed my suspicions that the fix was in even before the gavel went down to begin the hearing. What I had not realized was, at least according to some proponents of DSHEA, part of the deal was that consumers would have access to accurate information backing efficacy claims made for supplements and their safety. Nor had I realized that the weaknesses of DSHEA, which have become painfully obvious in the 20-plus years since the law was passed, were anticipated from the get-go and that Congress was well-informed of what they were. Finally, I was not previously aware of the provenance (shall we say) of the “experts” asked to testify at the behest of Sen. Hatch.

First, let’s set the stage on which this drama plays out, according to two excellent books on dietary supplements, Natural Causes and Vitamania. In 1991, Congress passed the Nutrition Education and Labeling Act (NELA). Most famously, NELA, for the first time, required that all foods bear the now-familiar nutrition label. It also required that any health claims made for foods be backed by “significant scientific agreement.” Rep. Henry Waxman and others wanted the same standard applied to dietary supplement health claims. After all, if food companies had to meet a certain standard to make health claims for, say, calcium in their products, why shouldn’t claims for the health benefits of calcium in dietary supplement form be held to the same standard? But the supplement industry knew it couldn’t survive under such stringent rules and Sen. Hatch made sure it didn’t happen. All parties agreed to let the FDA decide what standard should be required of supplement health claims and left it at that. (more…)

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

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CAM use and chemotherapy: A negative correlation

It turns out that the use of certain forms of CAM makes it less likely that breast cancer patients will receive the chemotherapy they need.

It turns out that the use of certain forms of CAM makes it less likely that breast cancer patients will receive the chemotherapy they need.

So-called “alternative” medicine is made up of a hodge-podge of health care practices and treatments based on beliefs that are unscientific, pre-scientific, and pseudoscientific. These modalities include practices as diverse as homeopathy, traditional Chinese medicine, reflexology, reiki and other forms of “energy medicine” based on vitalism, chiropractic, and naturopathy, and that’s a short list of the quackery that falls under the rubric of the term “alternative medicine.” Unfortunately, this unscientific, pre-scientific, and pseudoscientific hodge-podge of treatments rooted in nonsense is rapidly being “integrated” into real medicine, thanks to an unfortunately influential movement in medicine whose members have been seduced into thinking that there might be something to them and view “integrating” them into medicine as means of practicing more “holistic” and “humanistic” medicine. This “integration” started out by being called “complementary and alternative medicine” (CAM) but now among believers the preferred term is usually “integrative medicine,” largely because it eliminates the word “alternative,” which implies (correctly) that the modality is not real medicine, and “complementary,” which implies a subsidiary status, a status of being nice to have but not essential.

Particularly harmful is the hostility towards conventional medicine that often strongly correlates with use of alternative medicine. Indeed, some people even choose to rely on alternative medicine instead of real medicine to treat cancer. Unsurprisingly, the results of such a decision are generally not very good. Actually, they are almost always terrible. Very, very terrible indeed. Not surprisingly, the use of alternative medicine is associated with bad outcomes. Cancer patients who might have survived die because of it. It’s not as though it hasn’t been studied either, although the main studies I’m aware of tend to look at the bad outcomes in patients who choose alternative medicine. There is another question, and it’s one that a new study published in JAMA Oncology last week seeks to answer. It’s a study that briefly made the news, producing headlines like:
(more…)

Posted in: Cancer, Herbs & Supplements

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Where science meets supplements

Various herbal remedies and supplements.

Various herbal remedies and supplements.

For those of you that missed the Science-Based Medicine day at NECSS last week, I’ve put the highlights in the following post:

The supplement industry is big business, and the popularity of these products seems to keep growing. I once worked at a small independent pharmacy that specialized in supplements, homeopathy and “alternative medicine” as way to differentiate itself from the big chain pharmacies. A lot has changed in a decade. Today, even national chain pharmacies have aisles and aisles of herbal remedies, dietary supplements, and even homeopathy. Yet despite the preponderance of products on store shelves, there is little evidence to suggest that supplements are necessary or even improve health (and may even cause harm). The right for consumers to buy products for themselves, and make their own self-care decisions, is an important one that respects individual autonomy. Regrettably, the regulations of these products are so weak and ineffective that the sale of these products quite possibly harms, rather than helps, the average consumer. The system is rigged against consumers, and it prevents the use of supplements in an evidence-based way. (more…)

Posted in: Herbs & Supplements

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