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…)
Posts Tagged DSHEA
Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.
When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)
Most of us are fortunate to live in countries where we don’t have to worry about counterfeit drugs. We can be confident that the prescription we receive, or the drugs we purchase from the pharmacy, are of high quality and contain exactly what’s on the label. But in these same countries, there’s another group of products where the risks of counterfeits are very real – it’s among the dietary supplements that are often found on the same shelves. Dietary supplements are not regulated in the same way as drug products. The American supplement industry is a multi-billion dollar free-for-all with little meaningful safety or quality regulation. Supplement quality and safety issues are in the media regularly as a result. The most recent example comes from the New York State attorney general’s office. It has accused four large retailers of selling supplements that failed to contain labelled ingredients. Testing the products with a technology called “DNA barcoding”, the AG’s office concluded that most of the products contained little to none of the labelled ingredient. And they also found ingredients that were not disclosed on the label. The AG’s office has demanded these products be removed from store shelves, and the stores stand accused of fraud. (more…)
“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…)
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…)
When you pick up a bottle of supplements, should you trust what the label says? While there is the perception that supplements are effective and inherently safe, there are good reasons to be skeptical. Few supplements are backed by good evidence that show they work as claimed. The risks of supplements are often not well understood. And importantly, the entire process of manufacturing, distributing, and marketing supplements is subject to a completely different set of rules than for drugs. These products may sit on pharmacy shelves, side-by-side with bottles of Tylenol, but they are held to significantly lower safety and efficacy standards. So while the number of products for sale has grown dramatically, so has the challenge to identify supplements that are truly safe and effective. (more…)
I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:
It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:
Online discussions on the merits of alternative medicine can get quite heated. And its proponents, given enough time, will inevitably cite the same drug as “evidence” of the failings of science. Call it Gavura’s Law, with apologies to Mike Godwin:
As an online discussion on the effectiveness of alternative medicine grows longer, the probability that thalidomide will be cited approaches one.
A recent comment on my own blog, regarding the homeopathic product Traumeel, is typical:
If the scientific method is all that separates an accepted claim, ie Thalidomide, Vioxx, Bextra, Darvon, from mere anecdote, of what benefit is the Science?
As a non-scientist consumer, I’ll take the anecdotes and my own experience. Thank you.
If scientists want to be taken seriously, they must stop selling themselves to the highest bidder becoming corporate whores without a shred of decency. To my mind, that’s how the claims for Thalidomide, Vioxx, Bextra, Darvon were accepted, making the scientific method utterly worthless.
To this commenter, “science has been wrong before.” And that invalidates science, and apparently validates homeopathy. It’s a fallacious argument. But does thalidomide actually represent a failing of science-based medicine? No, not even close. It’s so wrong, it’s not even wrong. Thalidomide is good example of the importance of science-based medicine and why allowing alternative medicine to be sold in the absence of good science is a concern. (more…)
Editor’s note: This weekend was truly NIH grant crunch time. I have to get my final version of my R01 to our university’s grants office by Tuesday, or it might not get uploaded by the July 5 deadline. (Funny how electronic submission, which was supposed to make applicants’ lives easier, seems to have made them harder.) Consequently, I decided to take a few minutes and spiff up a post I did not long ago for my other blog and use it here, mainly because it is particularly relevant to our usual SBM topics. I’ll be back next time with something new.
The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.
Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:
It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, foreign and domestic. His name is Senator Orrin Hatch (R-UT), and he was just the subject of a writeup in the New York Times last week referring to him as a “natural ally” of the supplement industry:
David Kroll’s recent article on thunder god vine is a great example of what can be learned by using science to study plants identified by herbalists as therapeutic. The herbalists’ arsenal can be a rich source of potential knowledge. But Kroll’s article is also a reminder that blindly trusting herbalists’ recommendations for treatment can be risky.
Herbal medicine has always fascinated me. How did early humans determine which plants worked? They had no record-keeping, no scientific methods, only trial and error and word of mouth. How many intrepid investigators poisoned themselves and died in the quest? Imagine yourself in the jungle: which plants would you be willing to try? How would you decide whether to use the leaf or the root? How would you decide whether to chew the raw leaf or brew an infusion? It is truly remarkable that our forbears were able to identify useful natural medicines and pass the knowledge down to us.
It is equally remarkable that modern humans with all the advantages of science are willing to put useless and potentially dangerous plant products into their bodies based on nothing better than prescientific hearsay. (more…)