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…)
Posts Tagged dietary supplements
The publisher recently sent me a review copy of Quackery: The 20 Million Dollar Duck, by Tony Robertson. My first thought was “Do we really need another book on this subject? Don’t I know all this stuff already?” I was very pleasantly surprised. Robertson has ferreted out an impressive array of facts and details that I wasn’t aware of; and yes, we need as many good books on the subject as we can get. Each author has a somewhat different approach that may appeal to a different audience. Robertson’s book is a worthy addition to the canon. He is a retired gynecologist who practiced, taught, and still lives in Zimbabwe. He is a critical thinker who understands and promotes science-based medicine, and he brings a unique perspective, especially on subjects related to his specialty. The book is not just about charlatans, it’s about non-science-based practices wherever they are found, including in mainstream medicine and in Robertson’s own field of obstetrics and gynecology.
I expected to like the book after I read the Dedication “To those who appreciate the truth fairy rather than the toothed one” and the Acknowledgements: “To my teachers and mentors who encouraged me to think, always to question and only to accept where there is good evidence.” That could serve as a motto for all skeptics, scientists, and critical thinkers to live by: Think, question, and only accept where there is good evidence. (more…)
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…)
If you want money to pay for pseudoscience, but your pesky health insurance company is getting in the way, a Health Savings Account might be just the solution. And if the Health Savings Act of 2016, sponsored by the Big Supplement’s own Senator Orrin Hatch, becomes law, your opportunities will be greatly expanded.
First, let’s take a look at Health Savings Accounts and explore how they can be used to pay for quackery. Then we’ll see how Hatch’s Senate Bill 2499 (and companion House Bill 4469) would essentially force taxpayers to fund consumer purchases of unproven and potentially unsafe dietary supplements and “The One Quackery To Rule Them All,” homeopathy. Finally, we’ll look at how all of this might affect the presidential race.
What are Health Savings Accounts?
A Health Savings Account (HSA) is a personal account created exclusively to pay for current or future health care expenses. They have significant tax advantages:
- Contributions to HSAs are tax deductible;
- Withdrawals are tax-free as long as they are used to pay for qualified medical expenses;
- Interest earnings accumulate tax-free and the balance in the account at year’s end can be rolled over into the next year with no tax penalty.
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…)
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.
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.
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.
If there’s one thing that unites all countries and cultures, it’s our love of caffeine. Whether it’s coffee, tea or other foods, caffeine is the most widely consumed drug in the world — more than alcohol, and more than tobacco: 90% of adults worldwide consume caffeine daily. At doses found in food and beverages, the effects are predictable and the side effects are slight. But natural or not, caffeine is a drug; isolate the pure substance, and the risks change. It would be difficult for most people to drink 16 cups of coffee in a row, but that’s the equivalent of just one teaspoon of caffeine powder. If that doesn’t hospitalize you, a tablespoon of the powder will probably kill you. Yet despite the risks, there are no restrictions on the sale of caffeine powder. You can buy a 1kg bag for $35, which provides the caffeine of about 5,000 cups of coffee. Caffeine powder is freely available to buy because regulators treat it differently – not because of its inherent properties, but because it’s “natural” and sold as a dietary supplement rather than a drug. This is a regulatory double-standard that harms consumers. It’s leaving a body count. And it needs to change: (more…)
One of the greatest triumphs of marketing over evidence was the incredible rise of vitamin supplement use in the 20th century. Supplement makers successfully created a “health halo” around vitamins, and taking your vitamins became a virtue, something mothers told their children to do. The evidence, however, does not tell such a simple story.
In recent years it has become increasingly apparent that there are unintended consequences to taking vitamin supplements, and in fact there may be a net negative health effect. This is especially true for those who are healthy and don’t need vitamins, and for those who exceed the recommend dosages.
A recent review of the last 20 years of literature on the subject, presented at the American Association for Cancer Research 2015 meeting, found an overall increased risk of cancer among vitamin users. Dr. Tim Byers presented the study, which echoes the result of a 2012 review that he and others published. He specifically refers to two famous studies showing an increased risk of cancer from vitamins.
Vitamin D, the so-called sunshine vitamin, has generated a lot of attention in recent years. It has been claimed to benefit a wide variety of diseases, everything from cancer to multiple sclerosis. It is widely used along with calcium for bone health. It is added to milk and prenatal vitamins and is prescribed for breastfed babies. Some doctors are recommending everyone take it for prevention. Some CAM advocates are recommending it as a more natural way to prevent the flu than getting a flu shot.
It has been touted as a panacea; Michael Holick even wrote a book titled The Vitamin D Solution: A 3-Step Strategy to Cure Our Most Common Health Problems. Christiane Northrup praised it, saying “This information can save your life. Really.” (Really? I’m skeptical, and her recommendation is not enough to make me want to read the book.) Then there’s Jeff Bowles’ book The Miraculous Results of Extremely High Doses of the Sunshine Hormone Vitamin D3 My Experiment With Huge Doses of D3 From 25,000 To 50,000 Iu A Day Over A 1 Year Period. That one’s not on my reading list either; the tolerable upper intake level is 4,000 IU a day.
It’s hard to avoid the hype and just examine the actual scientific evidence without any bias. The United States Preventive Services Task Force has tried to do just that. It recently evaluated screening for vitamin D deficiency and concluded that the current evidence is insufficient to recommend either for or against screening. Predictably, their announcement has already led to misunderstandings and protests.