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Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation

Sisyphus

Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.

Society for Science-Based Medicine

Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century

All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)

Posted in: Announcements, Health Fraud, Homeopathy, Legal, Politics and Regulation

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Let food be thy medicine and medicine be thy food? The obsessive worship of “medicinal foods”

Let food be thy medicine and medicine be thy food? The obsessive worship of “medicinal foods”

Let food be thy medicine and medicine be thy food.

– attributed to Hippocrates

Who said anything about medicine? Let’s eat!

– attributed to one of Hippocrates forgotten (and skeptical) students

 

Who hasn’t seen or heard Hippocrates’ famous quote about letting food be your medicine and your medicine your food? If you have Facebook friends who are the least bit into “natural” medicine or living, you’ve almost certainly come across it in your feed, and if you’re a skeptic who pays the least bit of attention to what’s going on in the quackosphere you will almost certainly have seen it plastered on a picture as a meme, either using a picture of Hippocrates or pictures of plates of green, leafy vegetables, or both. I like to view the fetishization of “food as medicine,” to cite Hippocrates, as one of the best examples out there of the logical fallacy known as the appeal to antiquity; in other words, the claim that if something is ancient and still around it must be correct (or at least there must be something to it worth considering).

Of course, just because an idea is old doesn’t mean it’s good, any more than just because Hippocrates said it means it must be true. Hippocrates was an important figure in the history of medicine because he was among the earliest to assert that diseases were caused by natural processes rather than the gods and because of his emphasis on the careful observation and documentation of patient history and physical findings, which led to the discovery of physical signs associated with diseases of specific organs. However, let’s not also forget that Hippocrates and his followers also believed in humoral theory, the idea that all disease results from an imbalance of the “four humors.” It’s also amusing to note that this quote by Hippocrates is thought to be a misquote, as it is nowhere to be found in the more than 60 texts known as The Hippocratic Corpus (Corpus Hippocraticum).

As Diana Cardenes argues:

But Hippocratic doctors clearly saw a difference between food and medicines. In fact, food was considered as a material that could be assimilated after digestion (e.g. the air was also food) and converted into the substance of the body. For example, food was converted into the different parts of the body such as muscles, nerves, etc. By contrast, the concept of medicines at the time was a product which was able to change the body’s own nature (in terms of humor quality or quantity) but not be converted into the body’s own substance. Thus a food wasn’t considered a medicine. A possible root of the food-medicine confusion is the following cryptic phrase found in the work On Aliment: “In food excellent medication, in food bad medication, bad and good relatively”.3 This text is nowadays attributed to the Hellenistic period, but was considered to be Hippocratic in Antiquity by Galenus in particular.

Now, it is certainly true that Hippocrates and his followers used diet to treat many illnesses, it’s not really clear what sort of success they had. However, this ancient idea that virtually all disease could be treated with diet, however much or little it was embraced by Hippocrates, has become an idée fixe in alternative medicine, so much so that it leads its proponents twist new science (like epigenetics) to try to fit it into a framework where diet rules all, often coupled with the idea that doctors don’t understand or care about nutrition and it’s big pharma that’s preventing the acceptance of dietary interventions. That thinking also permeates popular culture, fitting in very nicely with an equally ancient phenomenon, the moralization of food choices (discussed ably by Dr. Jones a month ago).
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Posted in: Cancer, Nutrition

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Vani Hari, a.k.a. “The Food Babe,” finally responds to critics

WhatifItold

It’s no secret that we here at Science-Based Medicine (and many scientists and skeptics with a knowledge of basic chemistry and biology) have been very critical of Vani Hari, better known to her fans as The Food Babe. The reasons for our criticisms of her are legion. Basically, she is a seemingly-never-ending font of misinformation and fear mongering about food ingredients, particularly any ingredient with a scary, “chemically”-sounding name.

Not surprisingly, as the Food Babe has gained prominence her antics have attracted more and more criticism for her toxic combination of ignorance of chemistry coupled with fear mongering. The criticism started with science and medical bloggers and leaked into the mainstream press, most recently in the form of a recent NPR blog entry entitled “Is The Food Babe A Fearmonger? Scientists Are Speaking Out” that liberally quotes from yours truly and our fearless founder Steve Novella, as well the professor and chair of the Horticultural Sciences Department at the University of Florida, Kevin Folta, who in October complained about the Hari being invited to speak at his university, where she didn’t take questions after spewing her usual disinformation. Indeed, her most recent foray into fear mongering, an attempt to attack Starbucks for its pumpkin spice latte because it not only contains “no real pumpkin” but also contains a “toxic dose of sugar,” and—brace yourself—uses dairy from “Monsanto milk cows fed GMO,” failed.

With a book and media tour scheduled for early 2015, apparently the Food Babe is feeling the heat and has finally responded to criticism on Saturday in a rather long post entitled “Food Babe Scam: My Response To The Attacks On Me and Our Movement“. Utterly predictably, she started with a quote commonly attributed to Mahatma Gandhi, “First they ignore you, then they laugh at you, then they fight you, then you win.” Never mind that Gandhi almost certainly never actually said it. Rather, Nicholas Klein of the Amalgamated Clothing Workers of America did. It’s also a misquote of what Klein did say. What Klein actually said was, “First they ignore you. Then they ridicule you. And then they attack you and want to burn you. And then they build monuments to you.”

Yes, they did build monuments to Gandhi, but I highly doubt anyone will be building monuments to The Food Babe, either now or many years from now. Her response to criticism is worth examining, however, because her defense itself reveals the many flaws in science and reasoning that led to the criticisms in the first place. (more…)

Posted in: Nutrition, Public Health, Science and the Media, Vaccines

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Food for Thought

I am excited to tell you about a wonderful new endeavor that is helping to promote critical thinking about science and medicine. It’s a free online course on “Food for Thought” that offers a scientific framework for understanding food and its impact on health and society from past to present.

The “Food for Thought” course is a product of EdX, which offers online college courses from Harvard, MIT, and other prestigious universities. They provide videos with interactive features and access to online student communities. Students can audit a course and get full access to all the materials including tests, assignments, and discussion forums with no commitment, and can choose what and how much they want to do. (more…)

Posted in: Critical Thinking, Nutrition

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Food Allergies and Food Addiction

Last week I wrote about the CME presentations at an obesity course put on by the American Society of Bariatric Physicians. I saved the most controversial one for last. Dr. Kendall Gerdes is a former president of the American Academy of Environmental Medicine, which I have previously written about. The AAEM is not recognized by the American Board of Medical Specialties and is categorized by Quackwatch as a questionable organization. Dr. Gerdes spoke on food allergies and food addiction.

I wasn’t convinced: I thought much of what he said was questionable. I thought, as a challenge for our readers, it might be an interesting exercise to present his information without comment and let readers look for flaws and form their own opinions. At the end, I’ll offer some suggestions of things to think about.

He described the concept of food addiction as a powerful tool to free patients from compulsive eating. Patients may “have the experience of” being addicted to foods or have symptoms of hunger and of just not feeling well. Specific symptoms of food addiction include fatigue, fibromyalgia, GI symptoms, cardiac arrhythmias, asthma, rhinitis, arthritis and seizures. There is no “gold standard” way to diagnose food allergies. He relies mainly on avoidance and challenge. (more…)

Posted in: Nutrition

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Probiotics

Remember this picture when I start talking about your wife.

Remember this picture when I start talking about your spouse.

The Wall Street Journal has an assessment of probiotics in the Jan 13, 2009 issue entitled “Bug Crazy: Assessing the Benefits of Probiotics.” For some reason when I wander around the hospital on rounds people show me articles such as this and ask, so whatcha think about this? Probiotics are interesting. They are live bacteria given to treat and prevent diseases. It is one of those overlap areas for scientific medicine and so called alternative medicine. There are good clinical trials to suggest areas where these agents are of benefit, but other aspects of their use are blown out of proportion for the real or imagined benefit probiotics may provide. Much of alternative medicine where it overlaps with real medicine is the art of making therapeutic mountains out of clinical molehills. The Wall Street Journal article is the kind of reporting that drives. Me. Nuts. It drives me nuts because the reporting acts as if the underlying assumptions of the therapies are true. (more…)

Posted in: Basic Science, Science and Medicine, Science and the Media

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What’s for Dinner?

Diet advice changes so fast it’s almost a full-time job to keep up with it. Avoid cholesterol; no, avoid saturated fats; no, avoid trans-fats. Avocados are bad; no, avocados are good. Wheat germ is passé; now omega 3s are de rigueur. The supermarket overwhelms us with an embarras de richesses, a confusing superabundance of choices from “organic” to low-sodium. How can we decide what to have for dinner?

Michael Pollan, the author of The Omnivore’s Dilemma, has written a new book: In Defense of Food: An Eater’s Manifesto. He argues for a simplification of diet advice. He hones it down to seven words: Eat food. Not too much. Mostly plants. (more…)

Posted in: Book & movie reviews, Nutrition

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