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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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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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“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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This stimulant can kill, yet you can legally buy it online. Why?

Caffeine Powder

This stimulant drug is highly toxic and perfectly legal.

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…)

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

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Vitamins and Cancer Risk

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.

The 2011 SELECT trial found an overall increased risk of prostate cancer among men taking vitamin E. (more…)

Posted in: Herbs & Supplements, Nutrition

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Vitamin D: To Screen or Not to Screen?

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.

sesame-street-letter-d-s

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.

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Posted in: Herbs & Supplements

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Side effects may include liver failure

Liver

“Safe and natural.” It’s a marketing phrase attached to dietary supplements that’s often accepted as self-evident. The marketing works. Supplements have a strong health halo. But evidence suggests that this reputation may be undeserved. Not only are there continued questions about whether most supplements have any health benefits whatsoever, there is also evidence that they can be harmful. We can’t even be confident that what’s on the label is actually in the bottle. Just two days ago I was notified of another long list of supplements and remedies that the FDA had identified that were contaminated with prescription drugs. These warnings about products sold as supplements appear regularly. Some time ago I asked, “What’s in your supplement?“, and noted that contamination and poor product quality standards continue to raise questions about whether supplements can be used safely at all, because the harms, when they occur, can be catastrophic. No matter how you feel about their efficacy, we can probably all agree no consumer should lose an organ from taking a health supplement. But it can happen. (more…)

Posted in: Science and Medicine

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A Misguided Apology

A new book by Thomas Schneider, MD, offers A Physician’s Apology. The subtitle asks, “Are WE making you sick?” I was eager to read it, because I could think of many things doctors might be apologizing for: overdiagnosis, overtreatment, ordering unnecessary tests, pathologizing the vicissitudes of everyday life, offering misleading low-fat diet advice, misrepresenting inadequately tested treatments, not putting enough emphasis on prevention, prescribing medication before giving lifestyle changes a chance, etc. I was disappointed: his basic apology was “Truth is extremely hard to find in medicine and science, and I’m sorry,” which is true but is hardly his fault. Then he promises to “tell you a number of medical and scientific facts that are different from what many have always been told.” He blames commercials, creative marketing, and clueless doctors. Then he offers his own “truths” and his personal recipe for wellness. Some of these “truths” are questionable, and some are frankly wrong.

a-physicians-apology

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Posted in: Book & movie reviews

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John Oliver skewers Dr. Oz for his hawking of diet supplements

As regular readers of this blog know, Dr. Mehmet Oz had a very, very bad day last week, in which he received a major tongue lashing from Senator Claire McCaskill (D-MO) for the scientifically unsupported and irresponsible hyperbole he dishes out day after day on his syndicated daytime television show. Personally, I was tempted to pile on myself, but had to content myself with enjoying a couple of posts from a super secret blog in the run-up to the hearing (inviting Dr. Oz to testify is “like asking Al Capone to testify about U.S. tax policy or Stanislaw Burzynski about clinical trial design and ethics”), right after the hearing, and looking at the fallout from the hearing. I had even thought of asking my “friend” to combine the last two into an SBM-worthy post, but by the time that thought had occurred to me, the moment had passed.

One of the best takes I’ve seen on the whole “Oz-fest” last week comes from John Oliver on his HBO show Last Week Tonight With John Oliver. It’s a really long segment that takes up the last half of his show and features—don’t ask why—George R. R. Martin and a tap dancing Steve Buscemi. It’s hilariously spot on:

Most SBM readers will enjoy it. I promise. Oliver even correctly identifies Sen. Orrin Hatch (R-UT) and Tom Harkin (D-IA) as tools of the supplement industry and explains why dietary supplements in the U.S. are largely unregulated and the FDA and FTC have such limited powers to do anything about them preemptively.

Posted in: Herbs & Supplements, Humor, Nutrition, Science and the Media

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VacciShield: Pixie dust for an imaginary threat

vaccishield

I know by now I shouldn’t be, but I am still amazed by how readily so many people buy into the seemingly endless array of bogus sCAM nostrums. Many are marketed and hawked for the treatment or prevention of diseases that are poorly managed by science-based medicine. There are countless examples of dietary supplements that are purported to effectively treat back and joint pains, depression, anxiety, autism, chronic pain, and chronic fatigue; the list goes on and on. The lure for these treatments is at least understandable and, although frustrated that scientific literacy and rational thought loses out, I empathize with the desire to believe in them. On the other end of the spectrum is the even more ethically corrupt substitution of safe and effective treatments with products that are not. I encountered what I find to be possibly the most frightening and dangerous example of this recently at my practice. A family new to the area called to schedule a routine health-maintenance visit for their 5-year-old daughter. When our nurse reviewed the medical records the mother had faxed over, she noted that the child was unimmunized and explained to her that she would need to begin catch-up vaccinations. The mother matter-of-factly stated that her daughter was actually fully vaccinated with a vaccine alternative. She had received a series of homeopathic vaccines from a naturopath. I am not going to discuss this egregious example of sCAM here, though it was addressed in previous SBM posts.1,2 Instead I’d like to focus on another part of the sCAM spectrum. Here lies a form of sCAM that, in some ways, is even more difficult for me to comprehend. These are products invented, marketed, and sold solely for the treatment or prevention of fictitious diseases or problems that exist only in the realm of fantasy. (more…)

Posted in: Herbs & Supplements, Medical Ethics, Naturopathy, Nutrition, Science and Medicine, Vaccines

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