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The New England Journal of Medicine Sinks a Bit Lower

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:

 


Here’s the front cover:

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:

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Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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TIME Magazine, Dr. Oz, What to Eat, and Supplements

Here on SBM we have frequently had cause to criticize the media for poor science reporting and for spreading misinformation. Among many other individual offenders, we have criticized Dr. Oz for promoting alternative medicine on his TV show and gullibly promoting guests who pretend to talk to the dead and pretend to heal people with carnival sideshow tricks. We tend to be negative and critical because somebody has to do it, but it’s not pleasant.  For once, I have some good things to say.

The September 12 issue of TIME magazine was a Special Nutrition Issue. The cover featured pictures of food and the title “What to Eat Now: Uncovering the Myths about Food by Dr. Oz.” It devotes 7 pages to an article by him entitled “The Oz Diet: No more myths. No more fads. What you should eat — and why.” This is followed by a 5 page article by John Cloud “Nutrition in a Pill? I took 3000 supplements over five months. Here’s what happened.” Both articles have a rational, science-based perspective without any intrusions of woo-woo. (more…)

Posted in: Nutrition, Science and the Media

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Utah Senator Orrin Hatch: A pit bull in defense of the supplement industry

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:
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Posted in: Herbs & Supplements, Pharmaceuticals, Politics and Regulation

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“CAM” Education in Medical Schools—A Critical Opportunity Missed

Mea culpa to the max. I completely forgot that today is my day to post on SBM, so I’m going to have to cheat a little. Here is a link to a recent article by yours truly that appeared on Virtual Mentor, an online ethics journal published by the AMA with major input from medical students. Note that I didn’t write the initial scenario; that was provided to me for my comments. The contents for the entire issue, titled “Complementary and Alternative Therapies—Medicine’s Response,” are here. Check out some of the other contributors (I was unaware of who they would be when I agreed to write my piece).

Posted in: Acupuncture, Basic Science, Chiropractic, Energy Medicine, Herbs & Supplements, History, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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European Union “Ban” On Herbal Products

Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.

The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.

The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.

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Posted in: Herbs & Supplements, Politics and Regulation

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Do calcium supplements cause heart attacks?

Calcium is good for us, right? Milk products are great sources of calcium, and we’re told to emphasize milk products in our diets. Don’t (or can’t) eat enough dairy? Calcium supplements are very popular, especially among women seeking to minimize their risk of osteoporosis. Osteoporosis prevention and treatment guidelines recommend calcium and vitamin D as an important measure in preserving bone density and reducing the risk of fractures. For those who don’t like dairy products, even products like orange juice and Vitamin Water are fortified with calcium. The general perception seemed to be that calcium consumption was a good thing – the more, the better. Until recently. (more…)

Posted in: Herbs & Supplements, Science and Medicine

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Diet Supplements or Nutritional Supplements: A Ruse by Any Other Name is Still a Ruse

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly. Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again; and maybe by writing this post I can make it easier for new readers to find the information.
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Posted in: Herbs & Supplements, Politics and Regulation

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The risks of CAM: How much do we know?

Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals

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For shame, Dr. Oz, for promoting Joseph Mercola on your show!

I’ve been highly critical of Dr. Mehmet Oz, Vice Chair of the Department of Surgery at Columbia University and medical director of the Integrative Medicine Program (i.e., Columbia’s quackademic medicine) program at New York-Presbyterian Hospital. Those are his academic titles. More important, in terms of his promotion of pseudoscience, is his role as daytime medical show host. Dr. Oz’s television show, called, appropriately enough, The Dr. Oz Show, is a direct result of his having been featured on Oprah Winfrey’s show on numerous occasions as one of her regular medical experts. Because of his popularity, Dr. Oz became Oprah’s protégé and ultimately scored his very own daytime TV show, which has been quite successful since its debut in September 2009.

So what has led me to conclude that I’ve finally completely had it with Dr. Oz? Or, as Popeye would say, “I’ve had all I can stands, I can’t stands no more!”

The final straw occurred yesterday, but this has been building up for a while. Of course, I’ve known for a long time that Dr. Oz has a weak spot for “alternative medicine.” A decade ago, he was known for bringing reiki masters into the operating room do their mystical magical gestures during cardiac surgery, the better to channel the healing energy of the “universal source” into his patients before they went onto the cardiopulmonary bypass machine. His wife is also a reiki master, which might explain his particular fondness for this form of faith healing. Even so, even though I always knew Dr. Oz was into some woo, most of the times I ever saw him on Oprah’s show and the rare occasion that I’ve seen his show, the worst I could say about him was that he is at best a shruggie and at worst too prone to mixing perfectly valid, science-based information with the “softer” forms of “complementary and alternative” medicine (CAM) modalities, such as acupuncture and reiki. Even so, CAM didn’t seem to be a major part of his show. That seems to have changed in 2010.

As 2010 dawned, I became aware of a show in which Dr. Oz promoted reiki completely uncritically, beginning the year with a show entitled Dr. Oz’s Ultimate Alternative Medicine Secrets. It wasn’t too long before Dr. Oz did it again, delivering a two-fer of “quantum” quackery coupled with just plain quackery, when he invited Deepak Chopra and Joe Mercola on his show. Around the same time, Dr. Oz also revealed in an interview also hadn’t had his children vaccinated against H1N1. In all fairness, he seemed embarrassed to admit this and uncomfortable about the situation (Dr. Oz has never, to my knowledge, expressed anti-vaccine views), but, even so, he did seem to be more sympathetic than the evidence warrants to the concept that vaccines might somehow cause autism. None of these occurrences was good, but, as disturbing as they were, none of them quite crossed a line. Quite.

As 2011 dawns, there is no doubt in my mind that Dr. Oz has now irrevocably crossed his Woo-bicon (link there to make my pun painfully obvious), gone over to the Dark Side, betrayed the cause, gone woo, or whatever you want to call it. He’s done, as far as science-based medicine goes. That’s because yesterday he featured one of the biggest promoters of highly dubious medical remedies on the Internet on his show in one fawning segment after another. I’m referring, of course, to Dr. Joe Mercola, who was the main guest on The Dr. Oz Show yesterday in segments entitled The Alternative Health Controversy (part 1, part 2, part 3), coupled with another segment entitled The Surprising Supplement You Need. Let’s just say that Dr. Oz’s journey to the Dark Side is now complete. He has controlled his fear but released his woo, and it is strong woo indeed.
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Posted in: Herbs & Supplements, Science and the Media

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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1
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Posted in: Homeopathy, Legal, Science and Medicine

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