When it comes to regulating and selling dietary supplements, should consumer interests be higher priority than those of manufacturers? While regulations are seemingly created to protect consumers, governments around the world have consistently given manufacturers the upper hand, prioritizing a company’s desire to sell a product over a consumer’s right to a marketplace with safe, effective products. Nowhere is this more the case than in Canada and the United States, where similar regulatory approaches have led to an industry boom and massive sales, but also a confusing marketplace for consumers and no persuasive evidence that all those supplements have any meaningful effects on our health. Drug store shelves in 2016 are packed with hundreds of products with unsubstantiated claims and untested products, and little credible information to guide selection. Since its beginnings, the contributors to this blog has been consistent in calling for more appropriate regulation: one that puts consumers first, not manufacturers, and evaluates all products (drugs, supplements or otherwise) with a consistent standard of science and evidence. Today, it looks like one regulator is preparing to move in that direction. Health Canada, Canada’s equivalent to the FDA, has proposed a new regulatory approach that is expected to block manufacturers from selling products with unsubstantiated and often misleading health claims. And they are asking for your input. Carly Weeks in the Globe and Mail writes, (more…)
Archive for Herbs & Supplements
It has been a long time since I first became aware of Mannatech, the multilevel marketing company that sells “glyconutrient” dietary supplements. After its claims were debunked and it lost a court case, it had dropped off my radar; but last month it came roaring back in the form of an email from a reader in South Africa. He said his in-laws had recently become Mannatech Sales Associates. Although the company can’t legally claim that their products cure any ailments, they continue to imply that their products give your body the tools it needs to cure itself. Company representatives and other advocates continue to claim in seminars and on the Internet that Ambrotose helps with a variety of conditions including MS, AIDS, cancer, lupus, colitis, diabetes, fibromyalgia, cystic fibrosis, ADHD, neuralgia, wound healing, and much more. There are even claims that it “cures” Down syndrome and even changes its characteristic facial features. My correspondent had done his own research and had concluded that Mannatech was marketing modern day snake oil with outrageous claims. But he was shocked that there was so little impartial information available about “glyconutrients.”
He is right: much of the available information about “glyconutrients” is from people who are trying to sell products; there isn’t much unbiased information available. Science-Based Medicine has not previously addressed “glyconutrients” or Mannatech except when Dr. Gorski recently wrote about presidential candidate Ben Carson, MD, shilling for Mannatech and claiming that Mannatech products had cured his prostate cancer. Let’s take a closer look at the science behind the claims for “glyconutrients.” (more…)
My exercise of choice is running. Despite the heat I’ve been having a great summer, training for the Chicago marathon. I’ve followed the training schedule fanatically since June. But it all came crashing down in one run last week when I moved from the ranks of “marathoner in training” to “injured runner”.
With the sudden onset of very sharp, radiating back pain, I was struggling to walk. My marathon plans seemed to evaporate. And in that moment of weakness, I became prey. Prey to pseudoscience, and prey to anyone offering a quick fix. (more…)
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…)
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…)
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.
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…)
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
- 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…)
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.
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…)
The first principle is that you must not fool yourself — and you are the easiest person to fool.
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…)