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:

A drive along mountain-lined Interstate 15 here shows why Senator Orrin G. Hatch is considered a hero in this region nicknamed the Silicon Valley of the nutritional supplement industry.

In the town of Lehi is the sprawling headquarters of Xango, where company officials praised Mr. Hatch, a Utah Republican, late last year for helping their exotic fruit juice business “operate without excessive intrusion” from Washington.

Up in Sandy, Utah, is 4 Life Research, whose top executives donated to Mr. Hatch’s last re-election campaign after federal regulators charged the company with making exaggerated claims about pills that it says helps the immune system.

And nearby in West Salem, assembly-line workers at Neways fill thousands of bottles a day for a product line that includes Youthinol, a steroid-based hormone that professional sports leagues pushed to ban until Mr. Hatch blocked them.

And, as the article goes on to mention, Hatch was the principal author of the DSHEA. Fast forward seventeen years, and these days any time the Obama Administration tries to write rules to regulate supplements more strictly, Orrin Hatch is there to do his damnedest to block them. Because Hatch is a very senior (and therefore powerful) Senator, he nearly always succeeds. Indeed, as the NYT article points out, the relationship between Hatch and Utah’s massive supplement industry been a hugely mutually beneficial one, and the article also describes just how incestuous it has been as well. First of all, there’s an enormous amount of campaign contributions that Hatch garners every election cycle from supplement manufacturers, but the relationship goes so much more deeply than that:

His [Hatch’s] family and friends have benefited, too, from links to the supplement industry. His son Scott Hatch, is a longtime industry lobbyist in Washington, as are at least five of the senator’s former aides. Mr. Hatch’s grandson and son-in-law increase revenue at their chiropractic clinic near here by selling herbal and nutritional treatments, including $35 “thyroid dysfunction” injections and a weight-loss product, “Slim and Sassy Metabolic Blend.” And Mr. Hatch’s former law partner owns Pharmics, a small nutritional supplement company in Salt Lake City.

But many public health experts argue that in his advocacy, Mr. Hatch has hindered regulators from preventing dangerous products from being put on the market, including supplements that are illegally spiked with steroids or other unapproved drugs. They also say he is the person in Washington most responsible for the proliferation of products that make exaggerated claims about health benefits.

Many are the times that I’ve complained about a different Senator, namely Senator Tom Harkin (D-IA) for his advocacy of pseudoscience that led hm to foist the atrocity that is the National Center for Complementary and Alternative Medicine (NCCAM) upon an unsuspecting nation. However, as bad as Tom Harkin is, he is nonetheless also widely appreciated as a staunch advocate of the National Institutes of Health and other funding for legitimate medical research. This has been true for decades, and he has been honored as such more than once. The problem is that, along with all that advocacy for the NIH, Harkin has a very hard time distinguishing worthwhile medical research from quackery. Even so, arguably he has supported enough good medical research that his unwavering support of NCCAM can almost be forgiven. Almost. Hatch, on the other hand, has no such redeeming quality to counterbalance his support for quackery and his defense of supplement manufacturers against any government law or regulation, no matter how reasonable, that might jeopardize their profits. Not surprisingly, he denies that this is true in the NYT article. He even has the gall to claim that he’s been a champion of regulating supplements, a claim that is so risible that it’s hard to believe he could make it with a straight face. I guess that’s why he’s a politician.

I am gratified, though, that the NYT didn’t forget to point out that there’s a new Republican quackery supporter in town, and he’s out to unseat Hatch by–you guessed it–sucking up to the supplement industry even more than Hatch does. His name is Jason Chaffetz, and he’s a former supplement company executive turned U.S. Representative and co-chair of the Dietary Supplement Caucus. (Yes, there really is such a thing.) I wrote about him not too long ago because of his support for what I then termed the “wonderfully Orwellian” Free Speech About Science Act of 2011 (FSAS). Boiled down to its essence, the FSAS would weaken even more the already desperately weak DSHEA. Basically, under the auspices of allowing “more free speech about food,” it would neuter the FDA with respect to claims about supplements, and it would do it through a very clever turnabout regarding the use of peer-reviewed research in that it places the burden of proof on the FDA to demonstrate that scientific studies used to bolster health claims for food and supplements are not good research. One can see the obvious problem with that. Supplement manufacturers could claim anything they wanted, as long as they could pull out a scientific paper or two, and it would be up to the FDA to have to refute them. Like the case for quacks, it wouldn’t be too difficult for supplement manufacturers to produce a constant stream of dubious research to point to, allowing the to make almost any claims they want to with impunity.

Fortunately, that law appears not to be going anywhere right now, and I hope it doesn’t. However, it was only a year ago that Hatch demonstrated why he is the master when it comes to protecting his supplement industry backers. That was when John McCain tried to pass legislation to tighten the regulation of supplements, Orrin Hatch and the supplement industry slapped him down in no uncertain terms. Basically, McCain ended up groveling before Orrin Hatch seeking absolution for his sins against the free market. The story is actually mentioned in the NYT article, as is Hatch’s attempts to intimidate the Obama Administration’s nominee for commissioner of the FDA, Dr. Margaret A. Hamburg.

So long standing and blatant has Hatch’s advocacy been that ten years ago Stephanie Mencimer wrote a devastating article for The Washington Monthly entitled Scorin’ with Orrin, an accurate description of Hatch’s activities then and now. To this day, Hatch remains in the pockets of the supplement manufacturers, and he has served them well, passing the DSHEA, a law that has been exploited by Utah companies like Xango:

But Xango’s record illustrates how companies eager to exploit the law can go too far.

In 2006, federal regulators warned Xango that brochures improperly promoted mangosteen juice as a disease cure, not just a healthy option. Xango is among more than a dozen Utah companies cited by federal regulators over the last decade for apparent violations of the law.

Xango, whose executives are the single biggest Utah-based contributors to Mr. Hatch’s political campaigns and have drawn Mr. Hatch to its headquarters to down shot glasses of their juice, blamed a marketing company that had printed the brochures. The company also insisted that it was closely monitoring distributors to make sure they did not make inappropriate claims.

But in his talk at Xango in March, Dr. Johnson — who lectures across the country at other company events — used some of the same language the F.D.A. had cited in its 2006 warning letter, and he referred the sales agents to a nearby company that still sold brochures making the improper claims.

Amusingly, this NYT article also includes a truly mind-numbingly idiotic statement justifying the activities of certain supplement companies from Dr. Johnson, so much so that even our very own Steve Novella labeled it the “Dumb Statement of the Week.” I think it has a real shot of winning far more than that:

One night in March, Dr. Vaughn T. Johnson, a Xango distributor, delivered part pep talk, part medical seminar, in describing extraordinary powers attributed to mangosteen. Studies showed, Dr. Johnson said, it was “anti-tumor,” “anti-obesity,” “anti-aging,” “anti-fatigue,” “antiviral,” “antibiotic” and “antidepressant.”

“How do I know this isn’t just snake oil?” Dr. Johnson, an osteopathic physician, asked. “It’s a really simple answer. A company that is selling snake oil is not going to stay in business for almost 11 years and grow as fast as this company is growing.”

In other words, because his supplements sell well, they must work. Anyone familiar with evidence- and science-based medicine knows that this is utter nonsense on steroids (which adulterate quite a few supplements, by the way). Placebo effects, confirmation bias, expectancy effects, and a number of other nontherapeutic effects can lead to the success of a product. Before the FDA existed, there were countless useless patent medicine products sold in this country that were quite popular. Heck, homeopathy is still popular in some parts of the world, and it’s just water!

It is with great irony that, having read this NYT article, I note how advocates of unscientific modalities frequently love to bash big pharma and insinuate that legislators are in the pocket of the drug companies. While it is true that pharmaceutical companies are heavy contributors to a number of legislators and wield considerable influence, pro-CAM apologists frequently contrast what they paint as big, soulless, corporations with local, mom & pop “natural medicine” businesses that big pharma is supposedly trying to crush, all in a nefarious plot to protect its obscene profits. However, as Orrin Hatch demonstrates, in the wake of the DSHEA of 1994, in the U.S. supplement manufacturers have themselves become quite a force to be reckoned with themselves. In states like Utah, supplement manufacturers can become far more powerful than pharmaceutical companies. One reason is that there isn’t much in the way of a pharma presence, big or otherwise, in Utah. There are, however, lots and lots of supplement manufacturers pushing all manner of poorly supported health claims to sell their products. Because these supplement manufacturers are very profitable and have a lot of money to throw around, it’s not surprising that they now also have a very powerful patron, too, in Orrin Hatch. As long as Hatch is in office, you can be quite sure that the DSHEA will stand, and, if Hatch has his way, sooner or later its remaining tooth will be pulled.

The question then becomes: What will happen after Hatch retires? He is, after all, in his late 70s. Clearly, it’s likely (although not a lock) that Jason Chaffetz will succeed him. If that happens, he will be even more in the pocket of the supplement manufacturers than Hatch has been over the years. Chaffetz will, of course, not have the seniority and long years of having built up political power and capital that Hatch has right now; so at first he is unlikely to be nearly as effective a protector of the supplement industry as Hatch has been. Still, that might offer a window of opportunity. The only time supporters of more science-based regulations of supplements will have a chance to do away with the DSHEA will be in the immediate wake of Hatch’s retirement or death, before his successor can accumulate clout.

Even at that time, I’m not optimistic that the DSHEA will ever be repealed.



Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.