There is an endless stream of supplement products on the market that are of questionable value. They tend to follow a similar pattern: put an essentially random assortment of vitamins, minerals, perhaps herbs and nutritional elements into a pill and then make whatever pseudo-health claims you want. Usually the claim is implied in the name of the product itself – sleepwell, or brainboost. The popular product Airborne fits this mold. It is essentially a multivitamin with the unfounded claim that it will prevent infection by boosting the immune system.
In the US, regulations (under DSHEA) specifically allow “structure/function” claims without any requirement for evidence to back up the claims. In other words, as long as you don’t mention a disease by name, you can make pretty much whatever claim you want. This was supposed to be good for the consumer, when in fact it is springtime for industry at the expense of the consumer. If your claims are outrageous enough the FTC can still go after you, but they are playing a game of whack-a-mole and losing.
Another pattern that is common is for a supplement product to contain specific components that are claimed to have specific benefits. Often these claims are based upon evidence – just the wrong kind of evidence. Basic science evidence is used inappropriately to support clinical claims. This strategy is more insidious, as it gives the public the sense that the product is science-based when it isn’t.
A correspondent asked me to review a video presentation by Steven Fowkes, “Nutrients for Better Mental Performance,” one segment of a 9-part series on preventing and curing Alzheimer’s that was mentioned recently by an SBM commenter. Fowkes is an organic chemist without a PhD; he says this means:
I am not institutionalized [This begs for a joke, but I will refrain.] and see the world differently. Everything I know I learned outside the system.
He is associated with CERI, the Cognitive Enhancement Research Institute and has written extensively on nutrition and health. I’ll comment on his claims for Alzheimer’s and herpes first, and then return to the “Nutrients for Better Mental Performance” video next week.
He says he can prevent Alzheimer’s disease and cure it in the early stages, although later damage will not be reversible. And yet he doesn’t actually specify the details of how he accomplishes that miracle: apparently it’s complicated (I would imagine so) and varies with the individual. Science doesn’t know what causes Alzheimer’s, but Fowkes does. The current thinking of scientists is that it is due to genetic factors interacting with environmental factors, and it might be a natural consequence of the aging process that would eventually affect anyone who lives long enough. Fowkes says it involves a complicated domino cascade of effects, but the cause boils down to loss of glutathione cycling and failure of sulfhydryl enzymes, which interferes with the detoxification of mercury in the brains of Alzheimer’s patients. (more…)
I’m fed up! In August 2009 I wrote about Protandim, pointing out that it’s not supported by good evidence. I thought I had made myself clear; but apparently I had only made myself a target. True believers have deluged the Internet with attacks on my article, calling it mere “opinion,” ignoring its main points, and denigrating me personally. I have ignored the Internet attacks, but I’m beginning to feel personally harassed: I have lost count of the e-mails I have received from Protandim enthusiasts trying to convince me that it works and that I should change my mind. I’ve spent hours trying to explain my reasoning in e-mails, and it’s becoming a repetitive chore, so I am writing this so that next time I get an e-mail inquiry I can simply forward this link.
What Is In It?
Protandim is a mixture of milk thistle, bacopa extract, ashwagandha, green tea extract, and turmeric extract (all of which, incidentally, can be purchased individually at much lower cost).
What Do They Claim It Does?
As described on Wikipedia:
The manufacturers of Protandim claim the product can indirectly increase antioxidant activity by up-regulating endogenous antioxidant factors such as the enzymes superoxide dismutase (SOD) and catalase, as well as the tripeptide glutathione, and by activation of theNrf2 pathway.
Nrf2 is a transcription factor that upregulates the expression of various genes that may regulate oxidative stress. Drugs to target that pathway might have benefits for diseases that are caused or exacerbated by oxidative stress. Such drugs are investigational at this point, but the makers of Protandim have skipped the investigational stage and are marketing a product that they think is effective for almost every ailment known to man and that they are promoting as an anti-aging supplement.
I seem to be writing a lot about the urinary tract this month. Just coincidence, I assure you. As I slide into old age, medical issues that were once only of cursory interest for a young whippersnapper have increasing potential to be directly applicable to grumpy old geezers. Like benign prostatic hypertrophy (BPH). I am heading into an age where I may have to start paying attention to my prostate (not prostrate, as it is so often pronounced, although an infection of the former certainly can make you the latter), so articles that in former days I would have ignored, I read. JAMA this month has what should be the nail in the coffin of saw palmetto, demonstrating that the herb has no efficacy in the treatment of symptoms of BPH: Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.
It demonstrated that compared to placebo, saw palmetto did nothing. There have been multiple studies in the past with the more or less the usual arc of clinical studies of CAM products: better designed trials showing decreasing efficacy, until excellent studies show no effect. There is the usual meta analysis or two, where all the suboptimal studies are lumped together, the authors bemoan the quality of the data, and proceed to draw conclusions from the garbage anyway. GIGO.
The NEJM study from 2006 demonstrated that saw palmetto was no better than placebo but it was suggested that perhaps the dose of saw palmetto was not high enough or that the patients were not treated long enough to demonstrate an effect, and the JAMA study hoped to remedy that defect. (more…)
Acupuncture is typically depicted as sticking needles at various points on the body prescribed (inconsistently, it turns out) by charts indicating purported “meridians” through which “qi” flows in the human, or animal , body. However, from one of the many SBM posts on acupuncture , this one by Dr. Novella , we in fact know that:
the consensus of the best clinical studies on acupuncture show that there is no specific effect of sticking needles into acupuncture points. Choosing random points works just as well, as does poking the skin with toothpicks rather than penetrating the skin with a needle to elicit the alleged “de qi”. The most parsimonious interpretation of the evidence is that the needles (i.e. acupuncture itself) are superfluous — any perceived benefit comes from the therapeutic interaction. This has been directly studied, and the evidence suggests that the way to maximize the subjective effects from the ritual of acupuncture is to enhance the interaction with the practitioner, and has nothing to do with the acupuncture itself. Acupuncture is a clear example of selling a specific procedure based entirely on non-specific effects from the therapeutic interaction — a good bedside manner and some hopeful encouragement.”
Unfortunately, those who draft state legislation do not read SBM. They should. If they did, they wouldn’t be enacting acupuncture practice acts. But they do.
Note: This was originally published as a “SkepDoc” column in Skeptic magazine under the title “Aspartame: Safe Sweetener or Perilous Poison?” and is reprinted here with the kind permission of Michael Shermer. There are other artificial sweeteners not specifically addressed here, but as far as I know there are no convincing health concerns about any of them, just this same kind of hype and fearmongering based on animal studies and speculation with no validation from human clinical studies.
Aspartame is a low calorie sugar substitute marketed under brand names like Equal and Nutrasweet. It is a combination of two amino acids: L-aspartic acid and L-phenylalanine. It is available as individual packets for adding to foods and it is a component of many diet soft drinks and other reduced-calorie foods. Depending on who you listen to, it is either a safe aid to weight loss and diabetes control or it is evil incarnate, a deadly poison that is devastating the health of consumers.
A reader sent me an ad from his local newspaper that recommended using stevia instead of aspartame and made these startling claims about aspartame:
- It is derived from the excrement of genetically modified E. coli bacteria
- Upon ingestion, it breaks down into aspartic acid, phenylalanine, methanol, formaldehyde, and formic acid.
- It accounts for over 75% of the adverse reactions to food additives reported to the FDA each year including seizures, migraines, dizzinesss, nausea, muscle spasms, weight gain, depression, fatigue, irritability, heart palpitations, breathing difficulties, anxiety, tinnitus, schizophrenia and death.
Let’s look at those claims one by one.
Like most people who grew up after April 22, 1970, I think it is important to be as environmentally responsible as possible. Like many I fail miserably much of the time, but at least I feel guilty about it. Recycling offers the opportunity to feel good about my environmental impact with little effort, since the garbage collection infrastructure in Portland makes recycling easy.
Some products are best extensively reprocessed before reused. Urine, as an example. There are proponents of topical and/or drinking urine as a treatment/cure for nearly any illnesses. The kidneys are mostly responsible for fluid and electrolyte balance and I realize that normal urine is mostly water, salts, urea and a smattering of other very dilute molecules. I have the urine tox screen to prove it. Urine is not a particularly noxious body fluid, but it is not high on my list of liquids to drink under normal circumstances.
Urine is mostly water but not an optimal source of water if it is your only source for fluids. Urine drinkers love to mention the occasional trapped earthquake victim who survives, in part, from drinking their own urine. For the first several days the urine would be dilute enough to keep people reasonably hydrated, as humans cannot concentrate urine as well as, say, a camel. So I can see where consuming urine for a short period of time would delay progressive dehydration and death. A couple days of drinking urine neat, shaken not stirred, would be harmless and, if there were no alternative sources of water, beneficial. I do suffer from the societal taboo that piss is icky, and for aesthetic reasons urine is not something I would want to consume, even when it is referred to as its more common designation ‘Coors Light’. (more…)
“I don’t want to give my child any drugs or chemicals for their ADHD,” says a parent. “Instead, I’m thinking about using caffeine. Sound strategy?”
It may be dispensed by a barista and not a pharmacist, and the unit sizes may be small, medium and large, but caffeine is a chemical and also a drug, just as much as methylphenidate (Ritalin) is. Caffeine is even sold as a drug — alone and in combination with other products. But I regularly speak with consumers who are instinctively resistant to what they perceive as drug therapy — they want “natural” options. Caffeinehas been touted as a viable alternative to prescription drugs for ADHD. But is caffeine a science-based treatment option? This question is a good one to illustrate the process of applying science-based thinking to an individual patient question. (more…)
It is an unfortunate truth that there is money in pseudoscience, particularly medical pseudoscience. Money both attracts charlatans and also funds their activities, which includes marketing pseudoscience and defending their claims from scientific scrutiny. In this way the game is rigged in favor of pseudoscience.
With0ut effective regulation, sites like ours are forced to play whack-a-mole with the medical pseudoscience du jour. The latest case in point is Titanium Ion Bands – which are just another version of the Power Balance bands that have been previously exposed as nonsense. The idea is that by wearing a small bracelet on one wrist you will experience improved athletic performance. This sounds impossible – because it is. But companies have successfully bamboozled enough of the public to rake in millions.
The marketing strategy is three-fold. First, get naive professional athletes to endorse the product. Second, give live demonstrations (deceptive parlor tricks) that convince the unsuspecting that something must be going on. And third, wow the scientifically illiterate with a confusing barrage of medical techno-babble. The combination is sadly effective.
Power Balance, for example, makes vague references to frequencies and energy as the explanation for how a little piece of rubber (with embedded holograms) can have any effect on human physiology. The company was eventually legally forced to admit: “”We admit that there is no credible scientific evidence that supports our claims.” The admission has not ended their sale, however.
As early as 2006, I used to be able to write monthly about US FDA warnings on erectile dysfunction supplements being found adulterated with prescription drugs such as sildenafil, the phosphodiesterase-5 inhibitor found in Viagra. These adulteration episodes raised the question of how many anecdotal reports of herbal products “working” had to do with them containing approved medicines.
So common was this practice that FDA created a site in 2008 that was dedicated to this problem: Hidden Risks of Erectile Dysfunction “Treatments” Sold Online. Indeed, these products were more commonly encountered from online retailers and not in health food stores. Other similar practices include bodybuilding supplement being spiked with anabolic steroids and weight loss supplements being adulterated with sibutramine (formerly Meridia), an anorectant removed from the market last year after showing increased incidence of heart attacks and stroke in patients with preexisting cardiovascular disease.