Science-Based Medicine

BACKGROUND: A BAD, BAD LAW

One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:
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A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.

Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

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In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA). This act allows for the marketing and sales of “dietary supplements” with little or no regulation. This act is the work of folks like Tom Harkin (who took large contributions from Herbalife) and Orrin Hatch, whose state of Utah is home to many supplement companies.

DSHEA has a couple of very important consequences (aside from filling the pockets of supplement makers). Continue Reading »

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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The Dietary Supplement Health and Education Act of 1994 (DSHEA) has been aptly described here at SBM as a travesty of a mockery of a sham. The supplement industry’s slick marketing, herb adulteration due to lack of pre-market controls, Quack Miranda Warning, and the many supplements for which claims of effectiveness failed to hold up under scientific scrutiny (e.g., antioxidants, collagen, glucosamine and hoodia) have been impaled on the sharp pens of SBM posters as well.

And we’re not the only ones. Investigations of the supplement industry (or, Big Supp) by reputable institutions such as the U.S. Government Accountability Office and the Institute of Medicine have resulted in numerous recommendations to improve dietary supplement safety by, in part, strengthening the FDA’s ability to effectively regulate the industry. Many of these have gone unheeded.

A recent federal law tried to ameliorate this situation by directing the FDA to take specific steps designed to increase supplement safety. Yet the ink of President’s Obama’s signature was barely dry when a bill was proposed in Congress to gut its provisions. In fact, there are now several bills pending in Congress which would actually weaken the government’s already puny regulatory authority over supplements. Yes, things could get even worse.

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“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are. After all, Who could argue with “health freedom”? How dare the government tell me what I can and can’t use to treat my own body? Of couse, as I (and others) have said many times before, in reality “health freedom” is a sham. In reality, “health freedom” is not an argument made for the benefit of the consumer; it’s an argument made for the benefit of the sellers of supplements. In practice “health freedom” really means freedom for quacks from any pesky laws and regulations that would prevent them from exercising their quackery.

So it was last week when I saw two websites known for anything but science-based medicine (SBM), namely the quackery-promoting website NaturalNews.com and the quackery apologist blog Vitamin Lawyer Health Freedom Blog promoting a bill that I hadn’t heard of before, namely H.R. 1364, entitled the “Free Speech About Science” (FSAS) Act of 2011. This bill is being touted in all the usual “health freedom” venues as an antidote to what supplement manufacturers apparently see as the “overreach” of the FDA. For example, Ethan A. Huff of NaturalNews.com (where’s Mike Adams, one wonders?) urges his readers to tell Congress to support the Free Speech about Science Act of 2011., while “vitamin lawyer” Ralph Fucetola subtitles his post HR 1364, S.216 and the Struggle for Health and Food Freedom Action Item. So what do these advocates for dubious supplements say?
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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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The bloggers here have been very critical of a law passed nearly 20 years ago, commonly referred to as the DSHEA of 1994. The abbreviation DSHEA stands for about as Orwellian a name for a law as I can imagine: the Dietary Supplement Health and Education Act. Of course, as we’ve pointed out time and time again, the DSHEA is not about health, and it’s certainly not about education. Indeed, perhaps my favorite description of this law comes from our very own Peter Lipson, who refers to it as a “travesty of a mockery of a sham.” Rather, it’s about allowing supplement manufacturers and promoters of so-called “complementary and alternative medicine” (CAM, with or without a preceding “s,” depending on your taste) who do not want pesky things like government laws and regulations to interfere with their selling of pseudoscience to market various compounds as “dietary supplements” with near-impunity. As Harriet Hall put it so accurately, the DSHEA is “a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines.”

The DSHEA accomplishes this by making a seemingly reasonable distinction between food and medicine and twisting it in such a way that allows manufacturers to label all sorts of botanicals and various other compounds, many of which have substances in them with pharmacological activity, and sell them as “supplements” without prior approval by the FDA before marketing. As long as the manufacturer is careful enough not to make health claims that are too specific, namely that the supplement can diagnose or treat any specific disease, and sticks to “structure-function” statements (“it boosts the immune system!”), almost anything goes, particularly if a Quack Miranda Warning is included.

Not surprisingly, given what a big business supplements have become in this country largely due to the DSHEA, manufacturers and CAM advocates fight tooth and nail against any attempt to update the DSHEA to correct some of its more unfortunate consequences. Led by Utah Senator Orrin Hatch and Iowa Senator Tom Harkin, who together make up a bipartisan tag-team in defense of the supplement industry and do their best to block any effort to increase its regulation by the FDA. We saw that most recently when Arizona Senator John McCain, of all people, introduced a bill in 2010 to try to tighten up the DSHEA and was thoroughly slapped down by Orrin Hatch. More recently, not satisfied with how good things are for the supplement industry, another Utah Representative Jason Chaffetz reached across the aisle to Jared Polis, teaming up to introduce the Free Speech About Science Act, which basically seeks to allow the supplement industry to make more liberal claims about its products. All it will need is a “peer-reviewed” paper to support it (Mark and David Geier would do!), and you can claim almost anything. Anything to grow the supplement industry, which is currently around $30 billion a year.

That’s why it’s critical, from time to time, to look at actual evidence, and just last week Maria Elena Martinez, PhD, of the University of California San Diego, and co-authors did in a commentary published online in the Journal of the National Cancer Institute entitled Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms.
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We advocate for Science-Based Medicine partly because science incorporates various generic intellectual virtues to which everyone should aspire. These include logical and clear thinking, unambiguous definitions, and internal consistency. In fact it is demonstrably true that opposing science often equates to promoting muddied and sloppy thinking, ambiguous language, and self-contradiction.

Last week I wrote about that latter virtue – consistency – and its lack when dealing with regulating physicians vs regulating so-called complementary and alternative medicine (CAM). In fact CAM exists, in my opinion, specifically to create a double-standard to disguise contradictory standards. It is institutionalized compartmentalization to minimize public cognitive dissonance.

This week, as promised, I will discuss how the same double standard has been made to apply to the regulation of supplements vs pharmaceuticals. The recently published Government Accountability Office (GAO) report on supplement regulation by the FDA brings this to light.

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I don’t much like Senator Tom Harkin (D-IA), and, I daresay, neither do any of my fellow bloggers here.

The reason should be painfully obvious. Arguably, no single elected official currently serving today (or ever) has done more over a longer period of time to promote quackery in the United States. I make this harsh assessment because Senator Harkin was the legislator who created the National Center for Complementary and Alternative Medicine (NCCAM) and has been its most powerful patron, promoter, and protector. It’s a center in the National Institutes of Health (NIH) of which we at this blog have regularly been quite critical, right from the very beginning, when I pointed out how our taxpayer dollars were being wasted on pseudoscience and quackery, while Wally Sampson provided some perspective on how this situation came to be and I gave a bit of history of NCCAM. Since then, we’ve been hammering away at NCCAM as a blight on the the science of the NIH, whether intramural or extramural.

Three years ago, we even managed to attract the notice of Josephine Briggs, the current director of NCCAM, who invited us to Bethesda for a meeting. It was a very cordial meeting, as described by Steve Novella and myself. Unfortunately, in the name of “balance,” Dr. Briggs turned right around and met with a bunch of homeopaths and then drew a false equivalency between us “skeptics” and proponents of quackery as represented by the homeopaths. Clearly, she didn’t get it, or, if she did get it, her position was such that she couldn’t bite the hand that feeds NCCAM. A year after that, NCCAM published a five year strategic plan, which I characterized as “let’s do some rigorous science for a change,” given that that’s about all it said. It’s a nice sentiment. We’ll see if it actually happens, although I doubt that it will. Although studying herbs is nothing but a form of pharmacognosy (natural products pharmacology) and studying lifestyle interventions is science-based medicine, neither of them are actually “CAM” per se, because there is nothing “alternative” about them other than their having been co-opted as a “foot in the door” grafted onto the more serious woo. Like a stray limb grafted onto Frankenstein’s monster, they don’t belong and don’t fit.

But I digress. NCCAM has that effect on me.

A Congressional champion of quackery decides to quack no more (after 2014, anyway)

It turns out that over the weekend, Senator Harkin announced that he will not seek a sixth term as a Senator:
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