Respectful Insolence

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.

Comments

  1. #1 Unity
    July 7, 2011

    You might be interests to note that over here in the UK, where we currently have homeopaths running scared thanks to our advertising regulator, the Advertising Standards Authority (ASA) taking responsibility for online advertising, the homeoquacks have tried to wriggle out of their problems by proposing a generic quack miranda for their websites.

    THe ASA said no deal.

    See – http://www.quackometer.net/blog/2011/07/1887.html

  2. #2 Dangerous Bacon
    July 7, 2011

    I think Dr. Denham and JAMA are right on target, though I winced at one complaint about the supplement industry, when Denham pointed out the risk of patients

    “taking health advice from medically untrained sales representatives.

    This offers too juicy a target for opponents who’ll point out the hazards involved in physicians taking advice from ‘medically trained” but heavily biased sales representatives of drug companies.

    By the way, the “Alliance for Natural Health” is not just a propaganda organization, it’s a front group for the supplement industry and derives funding from them according to Wikipedia (just who is involved and how much they pour into the ANH is not readily apparent, at least to a cursory online search).

  3. #3 augustine
    July 7, 2011

    And here’s the beef of the medical/pharmaceutical angst over supplements.

    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.

    It’s not that supplements are dangerous per se it’s that they fear people will forgo pharmaceuticals. It’s a trust and compliance issue. If their motives were pure and they were concerned about the welfare and health of their customers then they would work on the log in their own eye. Pharma wants to use government policies to eliminate competition and increase compliance. It’s great business politics.

    The good doctor has completely forgotten the context. Pharma products kill thousands and thousands every single year in the U.S. alone.

  4. #4 BGT
    July 7, 2011

    Augustine,
    You might want to re-read your quote for comprehension.

  5. #5 Jeff
    July 7, 2011

    Orac quotes Bryan E. Denham as stating,

    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.

    This makes it sound as if the FDA must go through some time-consuming legal process to recall a potentially harmful supplement. But the recently enacted Food Safety Modernization Act makes it clear this is not so. The agency can now order the immediate recall of any food product (including supplements) if it is merely suspected of being harmful.

    Mr Denham also claims that the FDA currently has “no premarket screening authority” for supplements. Not true. One of the provisions of DSHEA is called the New Dietary Ingredients Regulations: Any new supplement ingredient introduced into the marketplace since 1994 must obtain premarket authorization from the FDA – in its submission the manufacturer must include evidence of safety.

    On previous posts Orac has stated that supplements should be regulated like drugs since they sometimes have drug-like effects on the body. It is true that many supplements (and foods) can produce favorable changes to human metabolism. The US Department of Agriculture funded a study which found that rats fed freeze-dried blueberry powder had significantly higher bone mass than the placebo group. The researchers were trying to discover if blueberries might be an effective way to prevent osteoporosis. If human trials bear out this result, are we then supposed to get a prescription from an orthopedist if we want to consume blueberries or blueberry powder?

    The primary issue should be one of safety. Compared to prescription drugs supplements have a strong record of safe use – after all, they are already part of the human diet.

  6. #6 Scott Cunningham
    July 7, 2011

    Orac:

    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.

    It’s not just about the Quack Miranda warning. Supplement companies usually employ a multi-level marketing strategy, so when charges do come, they’re brought against the neighborhood woo peddler or ignorant grocery store clerk who claimed the supplement could treat a disease contrary to DSHEA, not the company that actually manufactures the stuff and makes most of the money. All the company brass has to do is disavow that they would ever claim their product could treat a specific disease and the teen-aged store clerk, encouraged to do make the forbidden specific claims by supplement trade magazines and store managers, takes the fall instead. (Natural Causes: death, lies, and politics in America’s vitamin and herbal supplement industry. Dan Hurley. Broadway Books, 2006. ISBN: 978-0-7679-2042-1)

    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.

    Tobacco. Haven’t you heard? It’s 100% healthy and definitely doesn’t cause lung cancer. Or esophageal cancer. Or mouth cancers. Or heart attacks. (cough, cough.)

    Sooner or later some clever businessman will market chewing tobacco as a herbal dietary supplement, and circumvent two sets of laws at once.

  7. #7 Orac
    July 7, 2011

    Ah, yes. It’s our resident morphing supplement industry apologist popping up right on schedule to spew his same, predictable talking points, straw men arguments, and slippery slope diversions, as he always does. (By the way, is your real name Jeff or John? You seem to alternate, having posted under both names at various times.)

  8. #8 Denice Walter
    July 7, 2011

    Actually, charlatans may wear the Quack Miranda as a “badge of excellence”: Gary Null tells his vic…*audience* to look up “exactly what the supplement does “because the “government won’t let us tell you”( paraphrases); thus the Miranda itself is proof of the government’s suppression of information as well as health freedom.

    Prior to the sales pitch, he might elaborately describe how a particular substance is necessary and “you don’t get *enough*”- usually going far beyond “structure/ function”, like “immune-boosting”, to more specific celluar activities- described by a long string of biochemical-sounding goobledygook interspersed with a “cytochime” here and an “oxidative stress” there- finalised with promises of the prevention and *cure* of serious illness. Realistic studies about a substance’s effects are blown out of proportion while more dodgy research ( like his own) is offered as Holy Writ. Confabulation reigns supreme.

    Offering a supplement as an alternate to prescribed pharmaceuticals is preceeded by an exaggerated listing of the pharmaceutical’s remotely possible side effects contrasted to the “naturalness” of the supplement, e.g. red yeast rice vs Lipitor. Another NYC area pharamacist/ nutritionist/salesman, Jerry Hickey ( owner of mall store/ mail order “Invite Health”) is a master craftsman in this venue. Highly concentrated food products as supplements are a specialty amongst this group: cherry extract, green tea capsules, pomegranate/ blueberry powders, and green concoctions are panacaeas for those “in the know”.

    During the “Great Recession” ( 2008-2009), CNBC reported an uptick in vitamin/ supplement sales (in the US/ slightly down, UK): this seems relevant because our woo-meisters often portray taking supplements as a sort of “insurance policy”; after they describe the effects of cancer and subsequent chemotherapy in horrifying detail, they introduce their product so you can avoid the nightmare entirely. A recent sales ploy I’ve encountered ( paraphrase**): “Even though you feel well *now*, you don’t *know* what unseen processes are secretly lurking within your own body: plaque is building up in your coronary arteries, cells may be beginning to transform into abnormal precursors to cancer.All because you ate junk food and didn’t exercise! You will find out when a heart attack or stroke occurs or when the doctor announces,’You have cancer’. Then what’ll you do?”.

    ( btw, where’s prn?)

    ** although I tried to dumb-down my parlance for accuracy, I do have limits.

  9. #9 Venna
    July 7, 2011

    I’ve just realized something… supplement salesmen/manufacturers are terrorists. Their job is to make us terrified to follow our doctor’s recommendations as far as sound medical advice goes because of the big, bad pharma-boogieman and also make us feel terrified to go on living without their product because we just might not be able to, go on living that is.

  10. #10 Calli Arcale
    July 7, 2011

    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.

    AFAIK, the only thing that comes close is the defense industry, where although contracts are officially decided based on competitive bidding, in practice, if you’ve got a sympathetic and well-connected legislator, you can get the contract regardless. (And not so coincidentally, one of the states that has especially benefited from this is Utah.) There are a lot of rules about the bidding process, designed to keep it all fair and above-board, but these weren’t really devised for the protection of taxpayers. That’s ostensibly the case, but really they were created at the behest of defense contractors. Fair bidding rules aren’t there to save us money; they’re there to protect defense contractors from other defense contractors.

  11. #11 Jeff
    July 7, 2011

    Orac: For the past couple of years I have posted only under the name of Jeff (my real name). I have no formal connection with the supplement industry. I do buy and consume many of their products – it’s how I stay healthy.

    There are genuine concerns with parts of the industry: drug-spiking, and companies making false or outrageous claims. But these are already illegal practices and could be dealt with by better FDA and FTC enforcement, as Senator Hatch rightly asserts. Bryan E. Denham is using a time-honored method among supplement industry critics. For example, putting melatonin in brownies (Lazycakes) was not only a bad idea, it’s also illegal – melatonin is not an approved food additive. But predictably, Illinois Senator Dick Durbin is using the Lazycakes incident to introduce new anti-supplement legislation. He claims falsely that the event necessitates stronger regulation, not simply better enforcement by the FDA.

    This is a probably Professor Denham’s real agenda: Not making supplements safe, but greatly restricting their use. There are many in Congress and academia who want to federalize all decision-making regarding healthcare (Obamacare is the first step in this process). To these people it is anathema that American consumers have the freedom to purchase a wide range of high-potency supplements. They believe stronger regulation and more government control is always a good thing – even when the product has an excellent record of safety.

  12. #12 Todd W.
    July 7, 2011

    @Jeff

    Let me ask you something. How does enforcing DSHEA prevent a manufacturer from slipping something like lazycakes or some other dangerous product into the market?

    One more question: why should supplement manufacturers be exempt from the regulations that are applied to drug manufacturers?

  13. #13 cervantes
    July 7, 2011

    Funny thing, you don’t see calls to legalize Ponzi schemes under the banner of “financial freedom,” or defective brakes as “auto repair freedom.” These products are making fraudulent claims. They do not in fact “boost the immune system.” Even if it’s unclear what that means, whatever it could possibly mean, they don’t do it. Fraud is fraud, no matter what category of product we happen to be talking about.

    BTW, there are some more defensible claims, e.g. saw palmetto for BPE, and although vitamin supplements generally haven’t fared well in RCTs there are are a couple of specific exceptions and arguably (narrow) categories of people who might benefit. Exactly how or where to draw the line is debatable, but it ought to be drawn.

  14. #14 JayK
    July 7, 2011

    Jeff is a PR man, it may not be for supplements, but probably something similar. His ability to leave out specific information and to carefully word his statements is something that seems to only come from those that have studied effective communication methodologies. Well done, Jeff! Now, can you tell everyone here how the supplement industry measures and maintains efficacy without RCTs in order to make any sort of claims of beneficial reactions? Also, the Big Scary Pharma people have to log every single reaction during their trials and report them as side effects. Are you saying that supplements are so amazingly awesome that they have no side effects and so reporting it would be useless, or are you aware the DSHEA protects them from having to publish that information? Since they don’t actually have trials, I guess there isn’t anything to report, though, right?

  15. #15 Dangerous Bacon
    July 7, 2011

    “Jeff”, who has “no formal connection” to the supplement industry says:

    “Mr Denham also claims that the FDA currently has “no premarket screening authority” for supplements. Not true. One of the provisions of DSHEA is called the New Dietary Ingredients Regulations: Any new supplement ingredient introduced into the marketplace since 1994 must obtain premarket authorization from the FDA – in its submission the manufacturer must include evidence of safety.”

    This is far from clear to me. What Congress is requiring the FDA to do is obtain premarket notification of new ingredients in supplements. The “evidence of safety” could mean nothing more than a supposedly safe history of use (i.e. testimonial-type evidence); no human clinical studies required according to the FDA website. If the FDA felt the notification filing was insufficient, it could label the product as “adulterated”, but my understanding is they could only get it pulled from the market by court action, since DSHEA prohibits them from using rulemaking to ban a product in this fashion. And by the time an understaffed and underfunded FDA ever got to the point of hauling a manufacturer/marketer into court (something that happens rarely), these people could easily have had a run of years of successful sales, then decide instead of fighting the court case to shut down and reopen as a new outfit selling more snake oil.

    If I am interpreting the NDI notification procedure wrongly, feel free to correct me. But it seems obvious that supplements still have a far lower bar to clear than pharmaceuticals when it comes to establishing safety, never mind efficacy.

    “Jeff”: On previous posts Orac has stated that supplements should be regulated like drugs since they sometimes have drug-like effects on the body. It is true that many supplements (and foods) can produce favorable changes to human metabolism”

    Why Jeff, shame on you for minimizing all the fantastic things supplements can do to “support” the function of our various bodily organs, immune health etc. Kudos though for suggesting that these fabulous “drug-like effects” can only be “favorable”, and that unlike drugs in general there are no trade-offs in terms of deleterious/side effects, only puppies and sunshine.

  16. #16 Anthony
    July 7, 2011

    Amusingly, speaking of enforcement, apparently the FDA has draft guidelines up for new dietary ingredients, and the supplements industry is upset (the FDA has apparently decided that a ‘new dietary ingredient’ is something that wasn’t marketed prior to 1994…).

    http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm

  17. #17 Orac
    July 7, 2011

    I notice that Steve Novella has also weighed in:

    http://theness.com/neurologicablog/index.php/good-critique-of-dshea/

  18. #18 The Analyst
    July 7, 2011

    This offers too juicy a target for opponents who’ll point out the hazards involved in physicians taking advice from ‘medically trained” but heavily biased sales representatives of drug companies.

    Exactly. When you have drug companies marketing drugs like Cipro as a safe first-line treatment for bladder/kidney infections, you know something is wrong.

    Of course, you probably think drugs in this class are great and all, because after all, they were approved by the FDA.

    And if you have patients that have CNS and neuropsychiatric symptoms from this drug, I’m sure you’ll blame it on the patient. And if their tendons rupture (perhaps months after stopping the antibiotic), I am sure you would deem that unrelated.

    I’m sure MMS (yes, chlorine dioxide) is generally safer than fluoroquinolones. In fact, I’d bet (a lot of) money on it.

    And you call these pharmaceutial reps medically trained? How about medically brainwashed? I’m sure most believe in what they do.

    There is a really interesting story of a pharmaceutical sales rep that quit representing Cipro and Bayer after having extensive permanent damage from taking the drug. I’ll have to dig that up.

    And I personally know a doctor who long-term neuropsychiatric symptoms, tendon pain, health problems, and a heart attack shortly after taking levaquin. She had to retire for a few years, but is now practicing part-time. She wasn’t exactly the most compassionate person, but she sure changed her tone after her experience.

    Bayer/Cipro reps troll the entire internet (it really doesn’t matter what type of blog you post on), so I expect a lot of pro-cipro responses. I dare you to trace their IPs. Many go right to Bayer.

    Some replies come from their Germany corporate headquarters at 212.64.228.99.

  19. #19 JayK
    July 7, 2011

    @The Analyst: Pharma-shill gambit, no citations (vague promise), and an incredulous argument of using cipro for a minor infection? Dude, you’re going for troll bingo, right?

  20. #20 Dangerous Bacon
    July 7, 2011

    Tu quoque is one of the most obvious and feeble debate fallacies.

    Even if there were close parallels between pharma reps touting useful drugs that come with a risk of side effects, and supplement advocates touting unproven drugs that also have toxic potential (the lack of a close parallel should be obvious), “they do it too” is not an effective response to pointing out the need for reform in the slack regulatory environment for supplements.

  21. #21 Ace of Sevens
    July 7, 2011

    Bah, you can get way vague than “boosts the immune system.” My favorite is “promotes wellness.”

  22. #22 The Analyst
    July 7, 2011

    JayK –

    I’ve been searching and I can’t find the blog post I am looking for. I am not talking about John Fratti either (he was a pharmaceutical representative for GlaxoSmithKline). However, there are plenty of stories if you want to look for yourself.

  23. #23 JayK
    July 7, 2011

    @The Analyst: I’m not even a medical doctor, yet I was able to find out the Levaquin, and the entire family of drugs, has a listed side effect of tendon pain and that it can exasperate certain heart problems. Less than 2 minutes of searching turned that up. It also was very clear that all drugs of the fluoroquinolone family are intended for life threatening stages of bacterial infection. Tons of easy to find information about them, so I assume you’re going to find a lazy doctor that prescribed Levaquin improperly and you’re going to use that as an example of how all doctors use it improperly, or something similar.

    Let me give you a little word of advice: you aren’t going to win this discussion. You’ve failed by setting your credibility so low, as I pointed out before. Don’t bother finding a blog post, in fact don’t bother responding until you understand what it takes for something to actually rise to the level of evidence.

  24. #24 Jeff
    July 7, 2011

    @Todd W.: In this warning letter the FDA states its regulatory objections to the addition of melatonin to a food product. These regs are not part of DSHEA:

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm201435.htm

    @Dangerous Bacon: The manufacturer of a New Dietary Ingredient for supplements has to file an NDI application with the FDA. The agency can then accept or reject the NDI filing. You’re right that the bar is much lower for NDIs than for drugs. The FDA wants to see data which gives “history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will be reasonably be expected to be safe.”

    But if you scoll down this page on the FDA’s website you’ll see many NDI filings which were rejected by the FDA on the basis of safety. When the FDA rejects an NDI filing, the manufacturer can’t legally market the product:

    http://www.fda.gov/Food/DietarySupplements/ucm109764.htm

    It’s extremely rare that a company will defy an NDI ruling and market the product anyway. Boyd Haley’s OSR#1 was one of those rare exceptions, and the FDA finally threatened legal action to stop its sale.

    @JayK writes that DSHEA protects supplement companies from making public any possible side-effects from their products.

    Huh? The Dietary Supplement and Nonprescription Drug Consumer Act of 2006 makes it mandatory that supplement companies report serious adverse events for their products. Unfortunately the FDA stopped posting these AER numbers for supplements after the first year of mandatory reporting (2008).

  25. #25 The Analyst
    July 7, 2011

    It also was very clear that all drugs of the fluoroquinolone family are intended for life threatening stages of bacterial infection.

    Only if that were true. What you read isn’t what goes on in the real world.

    Unfortunately, it is widely used as a first line treatment for minor infections such as a UTI. And most physicians I have talked to believe they are very safe even though the pamphlets are gigantic in size and say otherwise. The black box warning didn’t seem to change much either.

    And a tendon rupture can be relatively minor compared to possibility of severe life long CNS effects. The black box warning that they put in effect is not enough. An “increased risk of tendonitis” doesn’t sound so serious.

  26. #26 Gray Falcon
    July 7, 2011

    Any evidence for your claim, The Analyst? So far, we’ve got one anecdote that might be an isolated incident, a blog post that you can’t find, and several accusations you can’t prove. Even if they were true, the only conclusion one could safely reach is that strong regulation and scientific testing of medicine is required, and that would include the supplement industry as well.

  27. #27 Calli Arcale
    July 7, 2011

    I have recurrent UTIs, so I’ve used Cipro. My doctors have all favored other drugs, but sometimes when resistance develops, ciprofloxacin is a good way of putting it down.

    I don’t think UTIs should be dismissed too casually. There is a significant risk of permanent kidney damage if they are not treated promptly. That said, there is no reason to go for the more expensive drugs first. Amoxicillin is usually effective, is cheaper, and is safer. I’m not sure it’s really safer than the flouroquinolones, but it isn’t associated with the same side effects, that’s for sure. I really wouldn’t recommend being casual with *any* antibiotic.

  28. #28 Kat
    July 7, 2011

    My favourite is a TV ad here in NZ that suggests that you can only get your daily dose of Omega-3 by either taking *one* of their supplements, or by eating 3kg of salmon.

    Common sense tells me that humans don’t require 3kg of salmon per day to stay healthy.

    What concerns me is that when they say supplements are safe because ‘they are what we already eat’, there is no accounting for dose. I’m not suggesting too much Omega-3 is bad (I have no evidence), but equally there seems to be no requirement on the supplement companies to prove that their doses are safe (let alone necessary).

  29. #29 JustaTech
    July 7, 2011

    My father-in-law rents part of his warehouse to a guy who makes “herbal supplements”. (In part of a warehouse, yes.) A few years ago the guy was temporarily shut down because the “herbal supplement” he was selling for “male enhancement” was chemically identical to one of the ED-drugs (I don’t remember which one). It was a “patent infringement” issue, not a “making drugs in a warehouse using untested materials” issue, and I decided that I was never going to take any herbal supplement. If I really want some herb, I’ll grow it myself (with all the inherent dosing issues).

  30. #30 Chris
    July 7, 2011

    JustaTech:

    If I really want some herb, I’ll grow it myself (with all the inherent dosing issues).

    Back when I was on the Usenet newsgroup misc.health.alternative someone posted a question on where to buy herbs. I answered with a link to a seed catalog’s webpage on herbs.

  31. #31 Krebiozen
    July 7, 2011

    @The Analyst

    I’m sure MMS (yes, chlorine dioxide) is generally safer than fluoroquinolones. In fact, I’d bet (a lot of) money on it.

    How much would you like to bet? MMS is sodium chlorite, by the way, and is converted to chlorine dioxide gas by the addition of an organic acid before consumption.

    MIC for chlorine dioxide and S. aureus is about 0.02% or 200 mg/l, for other pathogens such as E. coli the MIC was 10-fold higher.

    MIC for ciprofloxacin and S. aureus is less than 4 μg/ml = 4 mg/l so ciprofloxacin is at least 50 times more toxic to bacteria than MMS.

    LD50 for sodium chlorite in rats is 284 mg/kg. Assuming the same susceptibility in humans, a lethal dose of sodium chlorite in a 70 kg human would be about 20 grams. A near fatal suicide attempt using 10 grams of sodium chlorite has been reported.

    LD50 for ciprofloxacin in mice and rats is >5000 mg/kg. Assuming humans are equally susceptible a lethal dose of ciprofloxacin would be 350 grams. A
    12 gram overdose of ciprofloxacin that produced only mild symptoms has been reported.

    To summarize, compared to MMS ciprofloxacin is at least 50 times more toxic to bacteria, but about 17 times less toxic to mammals. That is ciprofloxacin’s therapeutic index is more than 800 times better than MMS’s.

  32. #32 Lisa J
    July 7, 2011

    Orac, I would love to see you do a piece on this. You are probably VERY aware of Jim Humble and “Miracle Mineral Solution.” Do you know he has announced an “MMS 2?” Or better yet, that what it is, and all of his round the world “church members” are purveying is SWIMMING POOL SHOCK. He tells them to grind it to powder, put it in capsules and tell people to take two capsules with several glasses of water..

    Then again, it is TOO easy, probably to write this up.

  33. #33 KT
    July 7, 2011

    The Analyst has mixed something partly true with something mostly wrong. Cipro is a commonly prescribed drug for uncomplicated UTI, with maybe a 30/70 split favoring Bactrim.

    But the side effects of the quinolones that he waves around aren’t taken into context: these side effects are seen in large doses or in normal doses given to patients with impaired renal function. it is dose-responsive, not idiosyncratic.

    The standardized, small dose for UTI causes few of those. GI upset I see in many patients, but a little nausea is nothing compared to the infection ascending to your kidneys…causing dosing at levels that will be far more toxic. You always have to remember that not treating the infection may cause far more harm than risking the few and slight side effects of the first-line antibiotics.

  34. #34 Denice Walter
    July 7, 2011

    Today, Mike Adams ( @ NaturalNews) warns how governmental interference with the supplement industry will destroy jobs and *kill* the economy- as well as health freedom and most of his customers.

  35. #35 The Analyst
    July 8, 2011

    But the side effects of the quinolones that he waves around aren’t taken into context: these side effects are seen in large doses or in normal doses given to patients with impaired renal function. it is dose-responsive, not idiosyncratic.

    This is simply not true. It is known that previously healthy people with no health problems can have a severe reaction from a single dose.

    I don’t think it’s known why these few have this type of reaction, but it happens. It also interacts with NSAIDS, and patients are often not told to avoid NSAIDS by their doctor.

    Recent fluoroquinolones have not been approved because of the associated toxicity, and toxic fluoroquinolones have been removed in the market in the past and replaced by… guess what?… toxic fluoroquinolones.

    In fact, Wikipedia had to move “Adverse effects of fluoroquinolones” to its own article since it is so extensive.

    One day we will look back at this class of medication and say, “WTF were we thinking.” In the mean time, we will keep practicing medical ignorance.

    Why are people here afraid to challenge bad medicine? A lot are for taking down the supplement industry with very little evidence of harm, but they fail to see and criticize flaws that are so apparent in their own system. Is it because you prescribe the drugs I speak of for uncomplicated UTIs? Is it true ignorance? Do you just not care? I don’t get it.

    In the mean time, pass me some drops of that MMS (chlorine dioxide) please. I will feel much safer. I’ll give you some Cipro or Levaquin with some of my left over Vioxx, and we can have a drink together.

  36. #36 Composer99
    July 8, 2011

    While first mentioning that the ugh troll quotes ‘thousands and thousands’ – after both he and Troll1Troll2 have provided very dubious ‘exact’ numbers – of iatrogenic deaths, I should note that in addition to committing a form of tu quoque fallacy, the ugh troll is committing a ‘count the costs, ignore the benefits’ fallacy (no fancy Latin name I can think of) with respect to science-based medicine and the implied reverse fallacy (‘count the benefits, ignore the costs’) with respect to sCAM.

    Adding in the strong likelihood that the iatrogenic numbers provided are padded up by conflating deaths which probably don’t belong grouped together, and we see yet more of the ugh troll’s typical, abominable, argumentation.

  37. #37 Krebiozen
    July 8, 2011

    @Lisa J

    Do you know he has announced an “MMS 2?”

    Yes, it’s calcium hypochlorite which will immediately break down into calcium chloride and chlorine gas when it hits the hydrochloric acid in the stomach. Chlorine gas really isn’t a good thing to have anywhere in your body. It amazes me that the same people who are concerned about tiny traces of toxins in food, cosmetics and vaccines, and avoid pharmaceutical drugs, are willing to ingest large doses of untested toxic industrial chemicals like MMS, MMS2 and OSR#1.

    Incidentally promoting MMS as a healing substance is quite clever since it is a gastrointestinal irritant which makes people nauseous, or even vomit and have diarrhea which can be attributed to its “powerful detoxifying properties”. The worse you feel the more good it is doing you. That’s nonsense of course, since the dose required to raise blood concentrations anywhere near high enough to kill any pathogen is going to make you very ill indeed.

    To kill S. aureus, as I mentioned above, requires around 200 mg/l of chlorine dioxide. One drop of MMS contains about 10 mg of sodium chlorite which is converted to a bit less than 10 mg chlorine dioxide. Assuming a person has 5 liters of blood and all the MMS is absorbed into the blood stream, it would require 100 drops of MMS to get blood levels high enough to kill S. aureus, in practice a lot more as not all the MMS will convert to chlorine dioxide and not all will be absorbed into the blood. Experiments with rats suggest only 30-35% of a dose is absorbed. In rats chlorine dioxide is not excreted in the urine, 90% of it is converted to chloride and the rest is excreted as chlorite so MMS is useless as a treatment for UTI.

    Since most people have difficulty consuming the maximum dose of 15 drops that Jim Humble recommends without vomiting, I don’t believe it is possible to consume enough MMS to kill any pathogen without a risk of serious gastrointestinal irritation and possibly even methemoglobinemia and renal failure, especially in G6PD deficient people.

  38. #38 Vicki
    July 9, 2011

    It is also known that previously known people with no health problems can have life-threatening reactions to a single dose of ibuprofen. The question isn’t just whether a medication can be dangerous: it’s how often do these things happen, and what’s the tradeoff of risk versus benefit?

  39. #39 Patrick
    July 12, 2011

    Is there really any comparison between drug safety and supplement safety? It seems to me that there is a reason for lax regulations -death by drugs. I can’t recall anytime that supplements killed anyone except for the abuse of ephedra and what was that number? – probably under 10. Sadly my father was killed by an incompetent M.D. with a lethal and unnecessary drug combination. I am happy when I can treat myself with herbs rather than going to the bureaucratic medical system.

  40. #40 Antaeus Feldspar
    July 12, 2011

    It seems to me that there is a reason for lax regulations -death by drugs. I can’t recall anytime that supplements killed anyone except for the abuse of ephedra and what was that number? – probably under 10.

    Your logic makes no sense, Patrick. “There is a reason to regulate A very laxly, and that is that separate thing B is very dangerous!” Excuse me? Regardless of whether or not B is as dangerous as you make out, it doesn’t make A safe.

    As for your inability to recall more than one incident where supplements killed anyone, you’re ignoring quite a bit of silent evidence, namely those people who died of conditions that could have been treated by actual medicine but who were persuaded to forgo actual medicine in the mistaken belief that “supplements” would be as effective and somehow safer.

    This seems to be a chronic problem of yours; I remember someone showing up in the comments of a post about a child who died because she was given homeopathic “treatment” for a serious skin condition until it was too late to save her, and this person had nothing to say except how an incompetent physician had prescribed his father the wrong combination of drugs and thereby killed him. That was you, wasn’t it? Your comment there had no relevance to the post subject except if one chose to interpret it as “Here is an example of something bad that can happen with mainstream medicine; it proves that any alternative to mainstream medicine is automatically better,” which is of course completely illogical. What you implied there, you make explicit here; it remains nonsense.

  41. #41 will
    July 18, 2011

    No doubt Orac is comfortable with just about any anti-supplement bash published by AMA. They are two faces of a compromised industry on the defensive about exorbitant costs with needless mortality and morbidity.

    Natural medicine in the form of concentrated nutrients is displacing many less safe and less effective scripted medicines. Much lower retail costs can be an added benefit.

  42. #42 Bronze Dog
    July 18, 2011

    Will, have you actually ever considered finding out what we really believe instead of just spouting your prejudices?

    The Pharma Shill Gambit, by the way, is a form of immunization against evidence: Ad hominem and poisoning the well fallacies. It’s what the evidence says, not who you are, that determines what’s most likely to be true.

    What good evidence do you have that those “concentrated nutrients” are better than the standard care medicines? Here’s a hint: Growing popularity isn’t a useful measure. This isn’t some Ayn Randian Objectivist paradise where The Almighty Market determines what works best. Knowing what I know about humans and marketing, enough spin and indoctrination into sub-cultures can make even worthless products sell like hotcakes.

    That’s why people like me are more interested in things like randomized placebo-controlled clinical studies, epidemiology studies, and so on instead of inherently cherry-picked, biased, and self-deception prone anecdotalism.

    Of course, now that I bring up the use of rigorous studies instead of marketing testimonials to determine whether or not a treatment works, some of the stereotypical responses I hear from a lot of alties are:

    A) Alties are too arrogant to believe that they’re capable of self-deception or being confounded by alternate causes, therefore it’s self-evident that we should give them a free pass, and NOT have their products rigorously tested for safety or efficacy. Of course, they’d probably throw a fit if Big Pharma tried to make that same argument.

    B) Proper clinical trials are expensive, and it’s cheaper to just assume your product works, therefore we should cut allegedly small companies a free pass and never bother worrying if they’re releasing defective products.

    C) That corporations other than Big Pharma have the right to treat customers as guinea pigs and let the market sort out the survivors. It helps that a lot of altie gurus have formed a sub-culture where anecdotalist self-experimentation (or experimentation on children) is treated as acceptable and useful, despite countless opportunities for error.

    and D) For some reason, they think removing the hoops for them will not set any sort of precedent for removing those same hoops we demand of Big Pharma.

    Face it, alties are de facto (intentional or unintentional) allies of the corrupt portions of Big Pharma. More than a few are probably owned by them. By removing obstacles for themselves, they’re making it easier to remove those exact same obstacles we try to use to keep companies honest.

    If you want me to trust your product, you’ll have to jump through the same science hoops. Trying to convert this into a case of “Us vs. The Other” isn’t going to work.

  43. #43 Bronze Dog
    July 18, 2011

    Oh, yeah, Will… Do you know what probably made it possible for Frito-Lay to label unhealthy foods as ‘heart smart’?

    My first suspect would be DSHEA: IIRC, it’s the so-called Dietary Supplement and Herb Education Act. It labels a bunch of pills with health claims to be “food” and takes away much of the power the FDA has to regulate health claims made by things that are considered “food.” Obviously, that would include snack foods.

    Now is that irony, or hypocrisy at work?

    If those ‘heart smart’ chips are indeed unhealthy (or, at least, incapable of showing how they’re supposed to aid heart health) as we all suspect, we’d want the FDA to charge in and make Frito-Lay pay for false advertising.

    It’d be no surprise to me if it’s the supplement industry’s lobbying efforts that lead to Frito-Lay being able to make that claim without consequence. And people like you made it possible. That’s another reason why I think people like you are an unwitting ally to the corrupt portions of Big Pharma. If Big Supplement can do it, that means Big Pharma can do it, too.

    What I want is for all health claims to be subject to scrutiny and regulation, be they pharmaceuticals, food, vitamins, herbs (with or without the arsenic), or an industrial chelator in powder form being marketed as a hocus-pocus autism cure.

  44. #44 Yoga Teacher Training
    July 28, 2011

    yes, supplement companies do employ multi-level marketing to sell their products. It is big business and the product sells fast at a high price. I agree with Bronze Dog, “What I want is for all health claims to be subject to scrutiny and regulation, be they pharmaceuticals, food, vitamins, herbs (with or without the arsenic), or an industrial chelator in powder form being marketed as a hocus-pocus autism cure.”

  45. #45 Emily
    August 10, 2011

    Why is it so hard to believe that some consumers want the right to make their own decisions?

    Yes, the government has a responsibility to ensure that products are safe.

    Where you lose me is insisting the government has a responsibility to ensure that products are effective. Whatever happened to “buyer beware?” Do I not have the right to find out for myself if something works for me or doesn’t work for me?

    I’m tired of the government telling me what I can and can’t do with my own body when it’s not going to affect anyone but me! It’s the same mentality as the failed war on drugs that tries to tell people “beer is OK, cannabis is not.” Look: I don’t want poison in my beer or pesticides on my cannabis, but beyond that I want the right to consume whatever I please.

    I don’t want tainted supplements, but I want the right to consume them without the manufacturer having to go through so many hoops to prove efficacy that my $20 bottle suddenly costs $200. I’m satisfied that they work because I use them and I have learned first-hand that they work for me. Some of the supplements I take got me off of very expensive prescription drugs (for instance, I was able to discontinue Synthroid by taking a natural dessicated thyroid supplement plus iodine for a fraction of the price). I have tried a few supplements that didn’t work for me, so I stopped buying them. I don’t need the government to take it off the shelves to protect me from my own stupidity. Ease up, Big Brother, I got this one.

    No nanny state!

  46. #46 Emily
    August 10, 2011

    “If those ‘heart smart’ chips are indeed unhealthy (or, at least, incapable of showing how they’re supposed to aid heart health) as we all suspect, we’d want the FDA to charge in and make Frito-Lay pay for false advertising.”

    I don’t really care if Frito-Lay claims their chips are “heart smart.” Anyone with a nickel’s worth of common sense knows that potato chips are not health food.

  47. #47 Bronze Dog
    August 10, 2011

    Unfortunately, in this down economy, it seems increasingly few people can afford a nickel’s worth of common sense.

    Remember, for one example:

    We’ve got homeopaths who think diluted water can carry the vitalist essence of some plant that the original water touched that causes X symptoms under uncontrolled, unblinded conditions, and that a drop of this diluted water can then transfer that memory to a lactose or sugar pill, where it can cure an illness with X symptoms because the body can’t have two overlaps of the same symptom or something like that.

    These same homeopaths then go on to say in their loudest voice that their competitor only obsesses over symptoms, and does not treat the root cause.

    And, of course, we’ve got an entire industry built around the idea that you can buy a bottle of drugs, er, “herbal supplements” in pill form and pill-pop your way to a thinner you! (And legally cover their asses by putting “with diet and exercise” in very, very tiny text, alongside the Quack Miranda Warning so the FDA can’t regulate them, because tiny text and DSHEA makes herbal drugs into food, and therefore not drugs.)

    Common sense is rare, and the altie/supplement industry wants to keep it that way.

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