I just saw something I don’t see every day. Or every week. Or every month. Or even every year.
I frequently complain about supplements on this blog. Well, not supplements per se but rather the double standard we have in this country when it comes to supplements. Basically, supplements are about as close to unregulated as you can imagine, thanks to a law known as the Dietary Supplement Health and Education Act of 1994, or the DSHEA. Indeed, just last week, I wrote a post about a legislator whom I like to refer to as the lapdog of the supplement industry, namely Republican Senator Orrin Hatch of Utah, who, teamed up with his fellow defender of pseudoscience and the Senator who foisted the scientific atrocity that is the National Center for Complementary and Alternative Medicine (NCCAM) upon us, Senator Tom Harkin of Iowa, has crushed any and all attempts to strengthen the DSHEA and remove potential abuses.
So what did I see that so surprised me? An article in the latest Journal of the American Medical Association by Bryan E. Denham entitled Dietary Supplements–Regulatory Issues and Implications for Public Health. When I saw it, I thought two things. First, Dr. Denham thinks a lot like I do, and, second, given the overarching theme of this blog, just like the case with the anti-vaccine movement, it’s always a good time to discuss the idiocy that is the DSHEA. Actually, the DSHEA isn’t idiocy. Well, it is idiocy as public policy. However, from the point of view of supplement manufacturers and supporters of quackery, the DSHEA is pure genius. Here’s why, a described by DR. Denham:
Classifying dietary supplements as a subcategory of food, DSHEA allowed supplement manufacturers to market products without submitting proof of safety or efficacy to the US Food and Drug Administration (FDA). Currently, for a tainted or otherwise hazardous product to be removed from the supplement marketplace, an agency such as the FDA or the Drug Enforcement Administration must offer evidence that the product is unsafe, contains a controlled substance, or is absent ingredients listed on the product label after the product has appeared in retail outlets. For US health professionals, the fact that more than 150 million US residents use dietary supplements should be a point of concern as many users will almost certainly forgo conventional medical treatment in favor of using products that may offer no medicinal value and taking health advice from medically untrained sales representatives.
As I said, pure genius–if you’re a supplement manufacturer, particularly because the DSHEA in essence prevents the FDA from acting to ban a supplement as long as its manufacturers don’t claim that the supplement can diagnose, treat, or cure any disease. That’s the origin of what Peter Lipson dubbed the “quack Miranda warning” that you can find on so many supplement packages. Usually quack Miranda warnings say something like, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
The quack Miranda aside, however, manufacturers can make what are known as “structure-function” claims, such as that the supplement “boosts the immune system” and the like. And make such claims they do. Boy, do they ever! Often these claims are sufficiently vague as to be meaningless, with “boosting the immune system” being the prototypical example of such a claim. After all, “boosting the immune system,” can mean almost anything. If you think about it, boosting the immune system can actually be a bad thing, given that there is one condition where the immune system can be viewed as having been “boosted,” namely autoimmune diseases in which the immune system attacks the body. Be that as it may, a major problem with the DSHEA and how supplements are regulated (or, more properly, not regulated) is this:
The concern is that consumers may not differentiate between technical descriptions and marketing language and may attempt to use dietary supplements in place of medicines that have been tested in rigorous trials. To that end, a 2010 GAO investigation found that sellers of dietary supplements may actually encourage consumers to substitute supplements for physician-prescribed medications.
Don’t think that supplement manufacturers don’t know this, too. Or that they don’t take advantage of it. That is, of course, why the lapdogs of the supplement industry, Orrin Hatch and Tom Harkin, worked so hard to get the DSHEA passed in the first place, way back in 1994:
Counterintuitively, DSHEA became law 5 years after the L-tryptophan amino acid disaster of 1989, in which 38 individuals died and 1500 sustained adverse reactions. When the FDA appeared heavy-handed in its response to the supplement catastrophe, industry lobbyists began applying pressure to lawmakers, especially those with a vested political interest in the economic success of supplement companies. US Senator Orrin Hatch, representing Utah, a major producer of dietary supplements, responded to industry appeals by coauthoring DSHEA and shepherding it through Congress. In doing so, Hatch sought to help manufacturers enjoy the freedom they had profited from during the 1980s after the Proxmire Amendment of 1976 barred the FDA from using potency levels to classify dietary supplements as drugs. To date, no public official has defended the interests of the supplement industry to a similar extent.
Indeed not. No industry that I’m aware of has such a dedicated and unrelenting defender against any legislative threat as Orrin Hatch has been for the supplement industry. What surprised me most about Dr. Denham’s article is that it hit all the high points, so much so that it could easily be a post on Science-Based Medicine or, if pumped up with a bit more “insolence” and logorrhea, even on this blog. He mentions the cynical Free Speech About Science Act (HR 1364), which I discussed not all that long ago, calling it “wonderfully Orwellian.” Denham also hits the Dietary Supplement Safety Act, which John McCain initially introduced. Unfortunately, a combination of pressure from the supplement industry, a primary challenge from the right during the 2010 election that made McCain gun shy as far as seeming to be too much on the side of government regulation, and, of course, Orrin Hatch, forced McCain to abandon the bill. It’s a shame, as the DSSA would have required supplement manufacturers to register with the FDA and disclose all ingredients in their products. It would also have given the FDA mandatory recall authority, which would allow the FDA to require manufacturers to recall supplements suspected of being unsafe.
What I didn’t know before reading Denham’s article is just how clever Orrin Hatch can be in defending his paymasters from any legislative threat. Basically, Hatch dons the mantle of the responsible regulator, his favorite claim being that the DSHEA would be just fine if there were enough money to enforce it properly. Denham quite properly sees this argument as a load of fetid dingo’s kidneys:
With the support of industry lobbies, Hatch and Senator Tom Harkin persuaded McCain and Dorgan to drop S 3002, introducing in its place the Dietary Supplement Full Implementation and Enforcement Act (S 3414).8 Announced on May 25, 2010, S 3414, which also did not become law, proposed allocating additional monies to the FDA such that the agency could enforce DSHEA more effectively. Hatch has long argued that funding is the key to enforcement success, perhaps because the argument cannot be falsified; that is, whenever problems with DSHEA arise, proponents can simply request additional funding for enforcement efforts. However, such bills have amounted to little more than the perpetual tabling of legislative reform, leaving the FDA in the untenable position of having no premarket screening authority while simultaneously facing critics who blame the agency for not enforcing DSHEA.
I love the way Denham cuts right to the chase about how such an argument can’t easily be falsified and how it’s basically nothing more than an intentional ploy to delay or prevent actual legislative reforms. Without any premarket screening authority, the FDA can only act after something bad has happened, and the DSHEA combined with the lack of adequate funding to enforce the law guarantee that the FDA is virtually powerless to act except in the most egregious cases, such as when Boyd Haley tried to market an industrial chelator as a “dietary supplement” that can be used to treat autism.
Yes, with the DSHEA in place, the threshold at which the FDA feels safe taking action to protect the public is much higher than it needs to be.
Denham also sees right through the “health freedom” rhetoric, pointing out that the claims of protecting the freedom of choice of consumers are nothing more than a smokescreen that benefits supplement manufacturers. But it goes beyond that, beyond what even Denham suspected. For, it turns out, Orrin Hatch has even bigger fish to fry, and I discovered this courtesy of one of my “favorite” quacks, Robert O. Young, the man who thinks that all disease is due to excess acid. It was Young who pointed me to another bit of legislation introduced by Hatch (of course!) and Rep. Erik Paulsen (R-MN) called the Retirement Health Investment Act of 2011, (S.1098/H.R. 2010), which would:
expand the IRS code to include herbs, vitamins, minerals, homeopathic remedies, meal replacement products, and other dietary and nutritional supplements as “eligible medical expenses.”
The practical effect of this would be that health savings accounts could, if this bill becomes law, be used to pay for supplements, herbs, minerals, and homeopathy. Not surprisingly, the Alliance for Natural Health, a major “health freedom” propaganda organization, supports the bill. However, it and other organizations representing quackery aren’t entirely satisfied, mainly because they don’t think the bill goes far enough, as Young explains:
HSAs are savings accounts exempt from federal income tax at the time of deposit. Each year any unspent funds accumulate and “roll over” to the following year. To make use of HSAs one must be covered under a high-deductible insurance plan – but starting in 2014 the healthcare reform act will allow high-deductible or catastrophic healthcare insurance plans for people only under the age of 30.
This means that beginning in 2014, people over the age of 30 will not be able to purchase an HSA because they will not be eligible for catastrophic plans–making any changes to HSAs irrelevant to them.
The ANH and Robert O. Young, among others, want the bill amended to allow people over 30 to purchase catastrophic insurance with high deductibles. It’s not enough for them that taxpayers subsidize supplements for some people; they have to subsidize them for all people, the better to increase the profits of supplement manufacturers.
As Benham rightly points out in his JAMA article, few industries enjoy the level of protection that the DSHEA provides the supplement industry. That’s one reason why I sometimes laugh when promoters of “alternative” medicine rail against pharmaceutical companies, contrasting them to what they paint as “mom and pop” businesses selling supplements. In fact, supplements are big business. True, they’re not as big a business as pharmaceutical companies, but neither are they the innocent little mom-and-pop businesses they’re portrayed as, either. They’re big business, and they have a patron in Congress named Orrin Hatch that most industries would kill for.