Posts Tagged supplements

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.


Posted in: Herbs & Supplements, Legal

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To debate or not to debate: The strange bedfellows of Andrew Weil

Andrew Weil

To debate or not to debate, that is the question.
Whether it is nobler in the mind to suffer
The slings and arrows of outrageous quackery
Or to take arms against a sea of quackademia,
And, by opposing end them.

Hamlet, Act III, Scene 1, paraphrased badly.


The question of whether it is worthwhile to debate cranks, quacks, and advocates of pseudoscience has long been a contentious issue in the skeptic community. Those of you who’ve been reading my posts for a while know that I’ve always come down on the side that it is not a good idea One thing I’ve learned in my more than a decade of blogging, both here and at my not-so-super-secret other blog, is that advocates of pseudoscience love public debates. Indeed, whenever you see a skeptic agree to a public debate with an advocate of pseudoscience, it’s a damned sure bet that it wasn’t the skeptic who proposed it. I suppose it’s possible that there have been such instances that I’m unaware of, but I do know of a lot of instances where it was the other way around. I’ve even witnessed one myself, when our fearless founder Steve Novella debated antivaccine quack Julian Whitaker about vaccine safety at FreedomFest in Las Vegas while we were at TAM three years ago. Steve mopped the floor with Dr. Whitaker so dramatically that it almost changed my mind about the value of debates with quacks because, witnessing the debate, I saw that the arguments Dr. Whitaker marshaled were such hackneyed antivaccine talking points that I knew I could also have demolished them. Still, in the end, no minds were likely to be changed, and the question of vaccine safety was clearly being used as a tool to oppose school vaccine mandates or, as antivaccinationists like to call them deceptively, “forced vaccination.” Whether vaccines are safe and effective or not is a separate question from whether the government should mandate certain vaccines as a precondition for attending school or being in day care.

Over the years, I myself have been “challenged” to similar debates myself. Perhaps the most bizarre example occurred when someone claiming to represent HIV/AIDS denialist Christine Maggiore contacted me claiming that she wanted to arrange a debate between us. Maggiore, unfortunately, died a mere two years later of—you guessed it—AIDS-related complications. Although occasionally the ego gratification of being asked to participate in such events vied with my longstanding belief that debating cranks doesn’t sway anyone, sharing the stage with a real scientist does unduly elevate the crank in the eyes of the public. Besides, whatever the seeming outcome of the debate, you can count on the crank to declare victory and his believers to agree. In any event, science isn’t decided by the metrics used to judge who “wins” a public debate, which rely more on rhetoric and cleverness rather than science to decide the outcome. Finally, such debates are not without risks. Although Julian Whitaker, for example, was terrible at it, other cranks are adept at the Gish Gallop, and an unprepared skeptic or scientist can be made to appear clueless in front of a crowd that is almost always packed with supporters of the crank, not the skeptic.

Just last week, there was another “debate” challenge that led me to question my resolve not to debate cranks. It came from a most unexpected source.

Posted in: Medical Academia, Medical Ethics, Science and the Media

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Andrew Wakefield, the MMR, and a “mother warrior’s” fabricated vaccine injury story


As the time came to do my usual weekly post for this blog, I was torn over what to write about. Regular readers might have noticed that a certain dubious cancer doctor about whom I’ve written twice before has been agitating in the comments for me to pay attention to him, after having sent more e-mails to me and various deans at my medical school “challenging” me to publish a link to his results and threatening to go to the local press to see if he can drum up interest in this “battle.” I’ve been assiduously ignoring him, but over time the irritation factor made me want to tell him, “Be very careful what you ask for. You might just get it.” Then I’d make this week’s post about him, even though I wasn’t thrilled with the idea of giving in to his harassment and giving him what he wants.

That’s why I have to thank the ever-intrepid investigative reporter Brian Deer for providing me an alternative topic that is way more important than some self-important little quack and a compelling topic to blog about in its own right. Brian Deer, as you might recall, remains the one journalist who was able to crack the facade of seeming scientific legitimacy built up by antivaccine guru Andrew Wakefield and demonstrate that (1) Wakefield’s work concluding that the MMR vaccine was associated with “autistic enterocolitis” was bought and paid for by a solicitor named Richard Barr, who represented British parents looking to sue vaccine manufacturers, to the tune of over £400,000; (2) Wakefield expected to make over £72 million a year selling a test for which Wakefield had filed a patent application in March 1995 claiming that “Crohn’s disease or ulcerative colitis may be diagnosed by detecting measles virus in bowel tissue, bowel products or body fluids”; and Wakefield’s case series published in The Lancet in 1998 was fraudulent, the equivalent of what Deer correctly characterized as “Piltdown medicine.” Ultimately, these revelations led to Wakefield’s being completely discredited to the point where The Lancet retracted his paper and even Thoughtful House, the autism quackery clinic in Austin, TX where Wakefield had a cushy, well-paid position as scientific director, had to give him the boot. Yes, Wakefield is a fraud, and it’s only a shame that it took over a decade for it to be demonstrated.

As much as I hate how it took discrediting Wakefield the man as a fraud rather than just discrediting his bogus science to really begin to turn the tide against the annoying propensity of journalists to look to Wakefield or his acolytes for “equal time” and “balance” whenever stories about autism and vaccines reared their ugly heads, I can’t argue with the results. Wakefield is well and truly discredited now, so much so that, as I noted, his prominent involvement probably ruined any chance promoters of the “CDC whistleblower” scam ever had to get any traction from the mainstream press.

What is sometimes forgotten is the effect Wakefield’s message has had on parents. These are the sorts of parents who tend to congregate into groups designed to promote the idea that vaccines are dangerous and cause autism, such as the bloggers at the antivaccine crank blog Age of Autism, the equally cranky blog The Thinking Moms’ Revolution, or groups like The Canary Party. It is Wakefield’s message and the “autism biomed” quackery that it spawned that have led to unknown numbers of autistic children being subjected to the rankest form of quackery in order to “recover” them, up to and including dubious stem cell therapies and bleach enemas.

Posted in: Health Fraud, Homeopathy, Neuroscience/Mental Health, Vaccines

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Side effects may include liver failure


“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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VacciShield: Pixie dust for an imaginary threat


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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We’re a drug-taking, supplement-taking nation. So how do we do so safely?


Do you take a vitamin or dietary supplement? It’s increasingly likely that you do, as over half of all American adults took some sort of supplement over the past 30 days. Now there’s evidence to suggest that about one-third of all Americans are taking supplements and prescription drug at the same time, which is renewing questions about risks and benefits. The same study reveals that combining supplements and prescription drugs is more common among those with certain medical conditions, compared to those without.

Many of us supplement in the absence of evidence of benefit, or even medical need. For example, there is little persuasive evidence to suggest that routine supplementation with products like multivitamins is necessary. There are exceptions of course: Those potentially becoming pregnant, those on dietary restrictions (e.g., vegans), and those with demonstrable medical need are among the cases where there is a clear benefit to vitamin supplementation, for example. The majority of us take supplements, like multivitamins, for “insurance” rather than because we have a deficiency or medical need. The evidence for non-vitamin supplements, like herbal products, is just as questionable as it is for vitamins, with few products showing meaningful health benefits. Ultimately decisions about supplements come down to evaluations of risk and benefits. Since I started working as a pharmacist, I’ve always cautioned consumers about the quality concerns and efficacy with herbal products and supplements, and the resultant risks that make me very hesitant to suggest their routine use – especially when they’re combined with prescription drugs. Yet the evidence suggests that it’s occurring – with increasing frequency. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals

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An Apple a Day

We (the authors and editors) at SBM get accused of many nefarious things. Because we deliberately engage with the public over controversial medical questions, we expect nothing less. It goes with the territory. In fact, if there were a lack of critical pushback we would worry that we were not doing our job.

Still, it is disconcerting to see the frequently-repeated ideological accusations in response to simply evaluating and reporting the evidence. That is what we do here – follow the science and evidence. When that trail leads to a conclusion that some people do not like (usually for ideological reasons) a common response is to accuse us of ideology, malfeasance, being part of a conspiracy, or having conflicts of interest or ulterior motives. That is easier, I suppose, than engaging with us on the science.

One common accusation is that we are shills for the pharmaceutical industry, and downplay or ignore the benefits of diet and “natural” treatments. A search through the SBM archives demonstrates that this accusation is false – we criticize bad science and poor-quality control, regardless of who is committing it. Sometimes pseudoscience is used to promote a drug, sometimes a nutritional supplement, and sometimes pure magic. (more…)

Posted in: Nutrition, Public Health

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Do vitamins prevent cancer and heart disease?

It is a triumph of marketing over evidence that millions take supplements every day. There is no question we need vitamins in our diet to live. But do we need vitamin supplements? It’s not so clear. There is evidence that our diets, even in developed countries, can be deficient in some micronutrients. But there’s also a lack of evidence to demonstrate that routine supplementation is beneficial. And there’s no convincing evidence that supplementing vitamins in the absence of deficiency is beneficial. Studies of supplements suggest that most vitamins are useless at best and harmful at worst. Yet the sales of vitamins seem completely immune to negative publicity. One negative clinical trial can kill a drug, but vitamins retain an aura of wellness, even as the evidence accumulates that they may not offer any meaningful health benefits. So why do so many buy supplements? As I’ve said before, vitamins are magic. Or more accurately, we believe this to be the case.

There can be many reasons for taking vitamins but one of the most popular I hear is “insurance” which is effectively primary prevention – taking a supplement in the absence of a confirmed deficiency or medical need with the belief we’re better off for taking it. A survey backs this up – 48% reported “to improve overall health” as the primary reason for taking vitamins. Yes, there is some vitamin and supplement use that is appropriate and science-based: Vitamin D deficiencies can occur, particularly in northern climates. Folic acid supplements during pregnancy can reduce the risk of neural tube defects. Vitamin B12 supplementation is often justified in the elderly. But what about in the absence of any clear medical need? (more…)

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

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New concerns about the safety and quality of herbal supplements

If there is one aspect of “alternative” medicine that both critics and fans should agree on, it’s that products should be manufactured to high standards. What’s on the label should accurately describe what’s in the bottle. Product quality standards are essential, whether you’re using herbs or drugs. And when it comes to ensuring the products we buy are of high quality, we’re all effectively reliant on regulation to protect us. As a pharmacist, I can’t personally verify that each tablet in your prescription contains the active ingredient on the label. I am dependent on a supply chain that may stretch around the world. While the product manufacturer may be reputable, it’s only a regulator that can realistically verify and enforce production to strict quality standards. The same cannot be said for products like supplements and herbs which are regulated differently than drugs, and held to different, and in some cases, weaker standards. A weak regulatory framework, which doesn’t hold manufacturers to account, would be expected to result in a product of lower quality. And that’s exactly what you see when you look at supplements on the market today.


Posted in: Herbs & Supplements, Science and Medicine

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What’s in your supplement?

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…)

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

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