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Legislative Alchemy 2015: Another losing season for CAM practitioners

legislative-alchemy-image
One of the main, but perhaps underappreciated, reasons quackery thrives in the United States is that the states legalize it by licensing practitioners of pseudoscience as health care providers. These practitioners are placed under the regulatory jurisdiction of, well, themselves. I call the whole deplorable process Legislative Alchemy, and you can see all posts on the topic here. It gives practitioners an underserved imprimatur of state authority and leaves public protection from harmful practices to the oversight of those who are themselves engaging in the very same conduct. Each year, dozens of bills are brought before the state legislatures to establish initial licensure or, once that goal is achieved, scope of practice expansion.

Most attempts fail, but CAM practitioners are a dogged bunch, and they will come back each year until they get what they want. It took chiropractors about 60 years to become licensed in all 50 states. Acupuncturists are almost there. Naturopaths lag far behind, but are slowly gaining ground each year, even if it is only via practice expansion in states where they are already licensed. 2015 was a losing season for all, but not without advancement toward larger goals.

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Posted in: Acupuncture, Chiropractic, Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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The one thing you need to know before you detox

detox will to live small

New Year, New You, right? Here’s a perennially popular post, revised for 2016.

With 2016 upon us, it’s finally time get serious about your health. You’re resolving to eat better and exercise more. But first, you need to reset your body – and purge yourself of all of your lifestyle and dietary overindulgences. But how? The options seem limitless, and everyone has advice: There’s Dr. Oz, Gwyneth, and even your favourite Kardashian has advice: They’re all telling you how it’s essential to “detox”, “cleanse” and “flush” away all of your toxins. Your local pharmacy has an ever-growing section of products promising a newer, more pure you: supplements, homeopathy, ear candles, and an entire aisle of “detox kits” all promise to suck toxins out of your body. Don’t forget your local naturopath who sells IV vitamin drips as the detoxification solution to your problems. The approaches may differ but all the advocates are completely convinced of one fact: Detoxing will deliver a renewed body and better health. Not only will you look better, you’ll feel better. It is a new year. Wouldn’t a purification from last year’s habits (dietary and otherwise) of last year be the best way to start? Well before you pull out your credit card, there is one fact that “detox” advocates are reluctant to tell you. (more…)

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Nutrition

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Guess who pioneered chemoprevention through diet?

Listen to your science: Eat your vegetables.

This is an expansion of a post I did over on the Society for Science-Based Medicine blog about this time last year. The original post, which got far more traffic than is usual for the SFSBM, is a good example of how science works and the good that it can do. The hard work of real science illustrated here serves as a striking counterpoint to the slap-dash system of pseudoscience, which churns out fake diseases, causes, and cures by the dozen based on a fuzzy understanding of real science fueled by a healthy dose of imagination.

Naturopaths and “functional medicine” practitioners would have the public believe that they are the true experts on nutrition and health. Even though their nutritional advice contains a large serving of hooey and a big helping of dietary supplements, which they are happy to sell to patients.

So it was with great interest that I read the obituary of Dr. Lee Wattenberg in the New York Times.

Dr. Wattenberg published a landmark paper in the journal Cancer Research that reviewed 36 years of animal studies on the effects that certain compounds had on the development of cancer. The paper laid the framework for understanding how these compounds work. . . .

He showed that cabbage, brussel sprouts, cauliflower and broccoli inhibit the development of carcinogens. He isolated a compound in garlic that decreased “by a factor of three” the chances that animals injected with cancer agents would develop that cancer. He found two chemicals in coffee that neutralize free radicals, which are harmful chemicals commonly implicated in the onset of cancer.

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

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What’s in your Traditional Chinese Medicine?

A study found 92% of Traditional Chinese Medicine was contaminated with drugs, heavy metals, or animals including cat, dog, rat and pit viper.

An analysis of 26 Traditional Chinese Medicine products found 92% were contaminated with pharmaceuticals, heavy metals, or the DNA of animals, including traces of cat, dog, rat, or pit viper.

Two weeks ago I detailed the pervasive problem of poor quality supplements. The main reason for this seems to be weak regulatory standards that prioritize the rights of manufacturers to sell supplements over the rights of consumers to buy safe, high quality, properly-labelled products. Call it “health freedom“, where the freedom belongs to producers, who in many countries are largely freed from most of the quality and safety regulations that are in place for licensed prescription and non-prescription pharmaceuticals. The result of weak regulation is that few supplements sold on the market today have been properly tested for safety or effectiveness, and there are few quality standards for the production of these products.

Not surprisingly, there are persistent signs that consumers may face real risks to their health from using these products. Now a new study from Australia confirms what past studies have already shown: adulterated and contaminated herbal remedies are the rule, rather than the exception. They often contain undeclared ingredients ranging from potential allergens to heavy metals to endangered species. (more…)

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Politics and Regulation, Public Health, Traditional Chinese Medicine

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Holding the supplement industry to account: Can we learn from tobacco regulation?

When it comes to supplements, you can't trust what's on the label

When it comes to supplements, you can’t trust what’s on the label

The idea that “natural” products are safe and effective has been so effectively marketed to us that many don’t recognize it as a fallacy. Much of the supplement industry is built around an appeal to nature. Supplements are described as natural, gentle, and “holistic”. Medicine, especially prescription drugs, is the opposite. They’re “chemicals”. They’re risky and dangerous – just look at that list of side effects! Supplements are packaged beautifully, have impressive claims, and are for sale at Whole Foods. Drugs are hazardous: They may come in a plain vial, with warning labels, detailed information sheets, and cautious statements about their effectiveness. Is it any wonder that many consumers, when faced with health concerns or medical issues, instinctively think of supplements as a safer alternative? Purveyors of supplements and alternative medicine have leveraged this fallacy so effectively that it’s even guided the regulations that allow their sale. Regrettably, the result is a marketplace that puts consumers’ interests last. The supplement industry has completely stacked the odds against the consumer, challenging their ability to make informed decisions about their health. Most supplements on the market have never been properly tested for safety or effectiveness. And those that have been tested have largely been shown to be ineffective – or in the case of products like vitamins, often unnecessary. And while there are undoubtedly some ethical companies out there, the industry is regularly revealed to resemble a wretched hive of scum and villainy. Despite this, the industry has gone from success to success – in terms of sales, at least. In 1994 supplement sales were about $4 billion in the US. It’s now a $37 billion industry that is remains only lightly regulated – or largely unregulated. With recent action taken against fraudulent products, there are more questions than ever about how to force the supplement industry to make consumer protection a priority. A new paper in Drug Testing and Analysis makes a provocative suggestion: Local and state governments already regulate another hazardous product: tobacco. Can lessons learned from the tobacco wars improve the safety of supplements? (more…)

Posted in: Epidemiology, Health Fraud, Herbs & Supplements, Politics and Regulation, Public Health

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Australian review finds no benefit to 17 natural therapies

Iridology

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.

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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!

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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.
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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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