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The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?

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:

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. 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.

In other words, when a supplement is marketed it’s more or less the honor system. No registration with the FDA is required. After all, supplements are food, not medicine! In effect, the government can’t really do anything unless problems are reported after the supplement is marketed. Even worse, the definition of “supplement” has become very broad, as Quackwatch points out:

DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It 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.

In other words, under the DSHEA, substances that are clearly not foods can be marketed as supplements, including herbs and other botanicals (the vast majority of which are marketed as having a beneficial medicinal effect and some of which contain chemicals that do act as drugs). As long as the manufacturer is careful not to make specific health claims, it’s all good. In other words, a “nutritional support” statement claimed for a supplement must not be a “drug” claim; i.e., it must not claim that the supplement can be used for the treatment or prevention of a disease. Supplement manufacturers easily evade this requirement by making vaguer claims related to organs or systems, such as claiming that a product “boosts the immune system,” “supports heart health,” or something similar, often accompanied by what Dr. Lipson has sarcastically referred to as the “quack Miranda warning“:

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.

It doesn’t take too much searching to find supplement advertising that does claim to treat, cure, or prevent disease.

The DSHEA was the greatest boon to supplement manufacturers ever. In its wake, the supplement industry exploded, racking up huge increases in sales. Indeed, a recent GAO report estimated that the supplement industry has grown to a $23.7 billion industry in 2007. Moreover, so lax is the regulation of supplements that it took a very extreme and egregious act, namely the marketing of an industrial chelator as an “antioxidant” supplement for the treatment of autism, before the FDA finally acted. Over the years, supporters of science-based medicine and sound public policy have made efforts to alter or repeal the DSHEA. All have failed. Tom Harkin and Orrin Hatch are powerful patrons, and Utah is home to many supplement manufacturers, whose interests Hatch zealously defends. Indeed, when adulterated supplements manufactured in Utah caused Olympic athletes to test positive for banned drugs and the International Olympic Committee warned athletes to avoid banned supplements, particularly those manufactured in Utah, Hatch leapt to the defense of the supplement manufacturers:

…he [Hatch] has been unapologetic in his support for the supplement industry, having battled the FDA and other federal agencies over the regulation of vitamins, herbals, and other natural medicines for more than a decade…Hatch considers his 1994 law, DSHEA, a triumph on behalf of consumer health freedom. But a close look suggests that if anything, DSHEA (or the Hatch Act, as body builders call it) has left Americans “free” to serve as guinea pigs for a multibillion-dollar industry, much of which is built on a foundation of fraudulent claims, pyramid schemes, and lousy manufacturing practices.

We here at Science-Based Medicine have said much the same thing multiple times. Last week, I learned that yet another effort is being made to strengthen the DSHEA and close some of its loopholes. This effort comes in the form of a law under consideration, the Dietary Supplement Safety Act of 2010. It is a law proposed by, of all legislators, John McCain.

Can the Dietary Supplement Safety Act of 2010 fix the DSHEA?

On February 3, 2010 Senator John McCain (R-AZ) gave a speech announcing new legislation that he was introducing, the Dietary Supplement Safety Act of 2010:

Like many of you, I am looking forward to watching the Super Bowl this Sunday and the Winter Olympics later this month. However, a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy. Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.

It is for precisely this reason that today Senators Dorgan and I are proud to introduce the Dietary Supplement Safety Act of 2010. All Americans should know the exact ingredients of any dietary supplement they use and the FDA must have the tools necessary to ensure the safety of dietary supplements.

This legislation would require dietary supplement manufactures to register with the FDA and fully disclose the ingredients contained in the supplement. Surveys have found that a majority of dietary supplement users believe the FDA approves the safety of dietary supplements prior to market introduction. However, that is not the case. In fact, dietary supplement manufacturers’ advertised claims of safety and effectiveness are not reviewed or approved by the FDA.

The complete text of the bill can be found here. Perhaps the most promising aspect of the McCain-Dorgan Bill is that it provides the FDA with mandatory recall authority if a supplement is found to be unsafe or harmful. Part of the reason that the government could do little about, for example, ephedra, which it took the FDA over a decade to be able to ban, despite multiple deaths linked to supplements containing it. Perhaps the most notorious death attributed to ephedra-containing supplements was that of Steve Bechler, a pitcher for the Baltimore Orioles, who died of heat strokefollowing a spring training workout in 2003. The medical examiner found that ephedra toxicity played a “significant role” in Bechler’s sudden death. Sad to say that cleaning up sports seems to be the primary motivation behind Senator McCain’s decision to take on the DSHEA, rather than protecting the public at large, but, whatever his motivation, it is good to see a legislator trying to make some corrections to the abomination of a travesty that is the DSEA of 1994. Indeed, as long as 6 years ago, McCain appeared to get it:

McCain voted for DSHEA, the 1994 law that gutted the federal government’s authority to oversee supplements — and that triggered the explosive growth in the sale of everything from horny goat weed to bee feces. But he says: “I’m not satisfied at all. The bill I voted for, frankly, I was not as aware of it as I should have been.”

Now McCain would like to force makers of supplements or any substance that affects the human body to test their products before bringing them to market. Given that the supplement manufacturers have huge political influence in Congress — they can mobilize millions of loyal customers, and they have a powerful patron in Sen. Orrin Hatch, R-Utah — that’s not likely to happen.

The bill has a number of good features. One part that I like is that the DSSA mandates that all adverse events be reported to the FDA, including non-serious ones. As mentioned by Senator McCain, it also includes expanded power for the FDA to issue cease distribution and notification order requiring that the manufacturer cease sales and marketing of the supplement in question. It also provides a mechanism for a hearing within ten days for the manufacturer to defend itself against the charges. After the hearing, the FDA may then issue a formal recall if it finds adequate evidence that the supplement is unsafe. While it is true that the DSHEA does currently allow the FDA to ban supplements, it does not, as I understand it, give the FDA the power to issue a rapid order to cease distribution or to mandate a recall this quickly, nor does it require supplement manufacturers to register with the FDA. All in all, it is a welcome modification of a very bad law. Although it does not go far enough, it is a bill that supporters of science-based medicine should support.

Not surprisingly, the supplement industry is very much opposed to this bill. For example, the Council for Responsible Nutrition (CRN) was fast to respond to Senator McCain’s press conference. In a bit of denialist double-speak that would make tobacco manufacturers blush, the CRN had the audacity to claim that requiring the reporting of all adverse events, not just serious ones, would not do anything to protect consumers. Even more Orwellian, the CRN actually claimed with (apparently) a straight face that the supplement industry had lobbied to “increase the regulation under which the supplement industry operates” and to “increase funding for the FDA’s enforcement efforts.” It supports a different bill, the Senate Food and Drug Administration Food Safety and Modernization Act (S.510), sponsored by Senator Richard Durbin (D-IL).

My reading of Durbin’s bill is that, although it too has a number of good features, it does not really address the supplement industry, at least not directly. Rather, it concentrates primarily on sanitation, and adulteration, the inspection of food manufacturing facilities, and regulation of imported food. Indeed, it appears to be primarily an agricultural bill to regulate food safety, and it says nothing about supplements explicitly. Of course, given that the law considers supplements food, supplements would fall under the law, but the law doesn’t really look as though it would actually do much about supplements. Certainly, it would not require supplement manufacturers to report all adverse events. No wonder the supplement industry likes it better than the McCain bill. S.510 would do little or nothing to reform the DSHEA, and that’s how the supplement industry likes it. Indeed, founder executive director of the American Botanical Council, Mark Blumenthal, essentially said as much when he argued that a new law isn’t necessary, claiming that all that is necessary is “robust enforcement” of the DSHEA. That is, of course, laughable, because even if the DSHEA were enforced to the letter, the problem would remain, namely that the FDA can do nothing about harmful supplements until after the fact and or about deceptive health claims made by supplement manufacturers–again, which is just the way the supplement industry likes it. Indeed, the record of the supplement industry has been to push for the passage of the DSHEA, which weakened the FDA’s authority to protect the public against dangerous supplements, and to fight every substantive effort to fix that travesty of a law.

In fact, if you want the attitude of supplement manufacturers encapsulated, just look at the reaction of attorney Jonathan W. Emord, a flack for the supplement industry:

Emord said a requirement to report non-serious adverse events was “laughable”.

“If it is not serious why bother?” he wondered, noting ‘seriousness’ had not been defined. “Is it when the vitamin bottle drops to the floor and the cat eats every one?”

Of course, I could point out that the FDA does define serious adverse events. Basically an SAE is a complication that is either life-threatening or require hospitalization and requires mandatory reporting. Even then, there was no guarantee that an adverse event due to a supplement would be reported because often such events are not linked to various supplements that people take. However, there are quite a few adverse events that might not fall under the FDA’s definition of “serious” that are significant, and there is currently no requirement that these be reported.

I’m not a politician, nor am I a political blogger. I don’t know what the chances are that the DSSA will pass congress. I’m not very optimistic, though. For one thing, it’s being introduced by a Senator from the minority party, although Senator Byron Dorgan (D-ND) is a Democrat. More importantly, it’s likely to run into a buzzsaw of opposition, thanks to Senators Hatch and Harkin. On the other hand, the publicity of the Winter Olympics may help get this bill some traction, and the emphasis of athletes who have either been harmed or tested positive for banned substances, thanks to adulterated supplements. Still, my guess is that the bipartisan tag-team of woo, Senators Harkin and Hatch, will guarantee that the DSSA dies a quiet death. Hatch will do it for his campaign contributors in the supplement industry; Harkin will do it because he’s a true believer.

I’d love to be proven wrong, but doubt that I will be. After all, Senator McCain has been trying to tighten regulation of the supplement industry since 2004. For all the features it shares with the DSSA, I don’t think Durbin’s bill goes far enough because it doesn’t directly address supplements in a manner in which they need to be addressed to fix the DSHEA, and that is why I prefer the McCain bill at present. In fact, even the McCain bill doesn’t appear to go far enough in that it seems to leave the DSHEA largely intact in terms of what supplement manufacturers are allowed to say in their advertisements. Even so, the McCain-Dorgan bill strikes me as unlikely to pass unless there is a groundswell of public support for it, which is why I hope you will contact your Senators and tell them you support the bill and hope that they will support it too.

Whatever bill passes, the McCain or Durbin bill, as has been true for 16 years now, something needs to be done to fix the the DSHEA, or, as I like to call it, the Supplement Manufacturer’s Protection Act. As long as the DSHEA remains intact, it’s more or less the honors system for supplement manufacturers, and I don’t trust supplement manufacturers any more than many trust big pharma. In fact, in many cases, they are becoming one and the same. Big pharma recognizes profit potential when it sees it, and supplements can be marketed without all that pesky and expensive testing that are required for new drugs.

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

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110 thoughts on “The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?

  1. Amanda says:

    The FDA does indeed define a Serious Adverse Event

    A serious adverse event (SAE) is defined as:

    Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. 21 CFR 312.32.

    So in fact a SAE does mean a life threatening experience, but to say that it is not defined is an out right lie.

  2. David Gorski says:

    Why do you say it is a lie? It is possible that I simply was mistaken. In any case, reading your link, I conclude that I was in error. Consequently, I have altered the relevant text and even included a link to the relevant definition; it does not change the fact that the DSHEA is a very bad bill and that the supplement manufacturers’ responses to it are self-serving nonsense. In fact, it makes the statement to which I was responding look even more ridiculous. Thank you. Seriously. Changing that paragraph actually does make my post better, IMHO.

  3. Jeff says:

    Senator Durbin’s Food Safety Bill, S510 does address the supplement industry directly. It calls for annual registration of supplement companies, and gives the FDA mandatory recall authority for dietary supplements. These are also two of the provisions in McCain’s new bill – they are both supported by many in the supplement industry. The House has already passed the Food Safety bill. Durbin’s Senate version, S510, is expected to pass sometime this year.

    The rest of McCain’s bill is overkill. It is already a violation of federal law to adulterate a supplement with a drug (like a steroid). The FDA, under President Obama, is finally pursuing felony prosecutions of companies who market adulterated supplements. Here’s one example:

    http://www.nytimes.com/2010/01/21/business/21steroids.html

  4. apteryx says:

    The serious adverse events that have been reported to date are almost all from vitamin, mineral, or combination products – and most of them have nothing to do with those products. Someone took a vitamin then had a heart attack? More than likely the vitamin was not to blame; it may have been pure coincidence. AERs very rarely provide any real indication of causality, and seldom have complete information on the patient’s relevant pharma use, health history, etc.

    AERs for serious events are still worth collecting, because they can provide preliminary indicators of rare side effects (or of defective products in the case of concentrated minerals, etc.). But if you start collecting AERs whenever someone calls a company to say “I took your product and got a headache,” the resulting giant pile of reports will never tell us which, if any, of those products can actually cause headaches. The only purpose of doing that would be to give the anti-supplement zealots some gigantic number of “adverse events” to scream about.

  5. David Gorski says:

    The rest of McCain’s bill is overkill. It is already a violation of federal law to adulterate a supplement with a drug (like a steroid).

    Straw man. I know that it is already illegal to adulterate a supplement. The problem comes in when it is the supplements themselves that are biologically active compounds that can do potential harm, like various products containing various hormones or other substances that act as drugs. These supplements are not “adulterated.” The drug effects are why they are marketed and why people seek them out. What about when “supplements” are biologically active compounds, like various products containing human growth hormone? Or testosterone- or estrogen-like compounds?

    In any case, here is the text of Durbin’s bill:

    http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s510is.txt.pdf

    It doesn’t even mention dietary supplements once or their manufacturers, although implicitly such supplements would be considered food, based on the DSHEA and the act that created the FDA. Clearly, the Durbin bill is more about protecting the food supply from adulteration and contamination than it is about protecting consumers from supplements that may be unsafe even when completely unadulterated; i.e., when the ingredients of the supplements themselves are what is unsafe.

    The problem with supplements and the DSHEA is that supplements fall into a twilight area. Many of them aren’t really food, and some of them act as drugs (ephedra, for instance, before it was recalled). While it would probably be impractical to require testing akin to what is required before a new drug is brought to market by a pharmaceutical company, it is not unreasonable to treat these dietary supplements as different from vegetables, meat, and other foodstuffs from a regulatory perspective and regulate them with a stringency somewhere between that of food and medicine.

  6. Jeff says:

    What about when “supplements” are biologically active compounds, like various products containing human growth hormone?

    It is legal to buy HGH precursors which stimulate the pituatary gland to produce HGH. Actual Human Growth Hormone is legally available only with a doctor’s prescription.

    Some herbal supplements do contain active compounds. But it is worth pointing out how safe legal supplements actually are. The American Association of Poison Control Centers just released their annual report for 2008. During all of that year the AAPCC received only 1,205 moderate, and just 65 serious Adverse Event Reports for all catagories of dietary supplements. There were no deaths.

  7. Jeff says:

    Senator Durbin’s Food Safety bill would, for the first time, give the FDA mandatory recall authority for all the products it regulates, including dietary supplements. This would prevent another Ephedra-like incident from occuring. This is why supplement trade groups, like the Council for Responsible Nutrition, supports mandatory recall for supplements.

  8. Scott says:

    Unfortunately, the bill doesn’t seem to address how “structure/function” claims allow supplement vendors to tell pretty much whatever lies they want to in order to market their products.

    During all of that year the AAPCC received only 1,205 moderate, and just 65 serious Adverse Event Reports for all catagories of dietary supplements. There were no deaths.

    Given the weakness of reporting, and in particular the difficulty of establishing whether a death was in fact due to a supplement, this means essentially nothing.

  9. David Gorski says:

    Unfortunately, the bill doesn’t seem to address how “structure/function” claims allow supplement vendors to tell pretty much whatever lies they want to in order to market their products.

    Precisely. That is the weakness of both the McCain and Durbin bills. Neither of them address the “structure/function” claims that allow supplement vendors to make whatever claims they want as long as they are careful not to get too specific about claiming that a supplement will treat or prevent specific diseases and include the “quack Miranda warning.” The Durbin bill, not being primarily about supplements at all (although supplements fall under it as “food”) doesn’t even consider this. At least the McCain bill recognizes supplements as a separate entity and, noting that they are in essence unregulated unless serious adverse events occur (and even then not very strongly), is trying to find a middle way between treating them as drugs and treating them as food. Unfortunately, however, even the McCain bill doesn’t go far enough because, as you say, it doesn’t do anything about structure-function claims.

    I should have emphasized that more in my post; I only mentioned it in passing.

  10. Scott says:

    Senator Durbin’s Food Safety bill would, for the first time, give the FDA mandatory recall authority for all the products it regulates, including dietary supplements. This would prevent another Ephedra-like incident from occuring.

    Not really. The REAL way to prevent another Ephedra is to require the manufacturer to demonstrate safety prior to marketing.

  11. Todd W. says:

    @apteryx

    Individual reports of AEs wouldn’t do a whole hell of a lot, true. However, with mandatory reporting to something like MEDWATCH, trends could be seen, which would then prompt further scientific investigation to determine whether there is a causal link or not. So, there actually is value in requiring mandatory reporting, particularly considering that many supplements are biologically active, having effects of their own on the body, as well as interactions with other drugs (e.g., St. John’s Wort and antidepressants, SJW and, IIRC, contraceptives, etc.).

    @Scott

    Precisely. The structure/function exemptions in DSHEA allow for way too much wiggle room.

    Orac, thanks for bringing this to our attention. I’ll definitely be writing my senators.

  12. Jeff says:

    Correction: S.510 would give the FDA mandatory recall for all food products it regulates,
    including dietary supplements.

  13. cervantes says:

    I don’t think the adverse events reporting feature is all that important in the scheme of things. Little of the harm done by the “dietary supplement” (i.e. quack potions) industry consists of recognizable acute events. Most of the stuff is probably innocuous, actually, although we don’t know that for sure; the harm there is just that people are being ripped off. (Don’t know if you can outlaw that, or should.)

    Some people may forgo effective treatment because they are suckered, but I think the supplement industry is a small part of that problem. Most people use them in addition to standard medical care, not instead of.

    The biologically active herbs may cause problems by interacting with prescription drugs, and there may be subtle, long term harms, as turned out to be the case, surprisingly, with high doses of some anti-oxidant vitamins. Some, e.g. saw palmetto, probably are actually effective for the purposes for which they are marketed but you get inaccurate dosing, may not be getting what you are paying for, and probably are getting weaker benefits.

    Ephedra and the stuff with anabolic steroids are really exceptions. And those can be dealt with under current law if the will is there.

  14. Jack123 says:

    What are you talking about guys? What is a biologically inactive supplement? I have never come across a single substances that was completely inert when absorbed. Virtually all supplements are biologically active…

    Many just have minuscle or weak effects or are not dangerous (or so one would hope). I guess *that* is what you mean by “active” and “inactive”?

  15. Todd W. says:

    @cervantes

    While AE reporting is pretty minor, in the grand scheme of things, it is at least a small step forward, as is the granting of authority to FDA to halt production/distribution and to force a recall.

    The real way to fix things, though, would be to enact pre-market safety testing, purity and potency requirements and tackle the structure/function claims. Unfortunately, the supplement industry would fight those measures even harder than mandatory AE reporting.

    @Jack123

    I suppose we’re differentiating between those supplements which make it past the digestive system and have non-neutral effects compared to those which either do not survive the digestive system (or other means of administration) or survive but have only neutral effects.

  16. jimpurdy says:

    Okay, let’s be consistent about regulations.

    Let’s ban tobacco, which is probably the # 1 lifestyle related cause of death.

    Then let’s ban alcohol, which is probably # 2.

    Then let’s cut way back on all the unnecessary medications from BigPharma, with all their life-threatening side-effects.

    Then get tougher with bizarre chemicals in our processed “food,” like aspartame.

    And how about getting serious abut very real food safety problems like e. coli and salmonella?

    Only after you do all those things, then go after those tree hugging hippies at Whole Foods who want to take Vitamins C and omega-3 fish oil.

    The 50 Best Health Blogs

  17. JerryM says:

    @jimpurdy – nice use of the false choice fallacy. You are perfectly free to call for any of those policy changes. You may even succeed.

    What is at hand atm is this bill, which on the face of it looks perfectly reasonable.

    Are you arguing against this bill for any other reasons?

    But sir, Jimmy jumped off the roof first!

  18. maus says:

    “It is legal to buy HGH precursors which stimulate the pituatary gland to produce HGH.”

    Homeopathic “precursors”, naturally. As are the fake testosterone products.

  19. rosemary says:

    Apteryx,”But if you start collecting AERs whenever someone calls a company to say “I took your product and got a headache,” the resulting giant pile of reports will never tell us which, if any, of those products can actually cause headaches. The only purpose of doing that would be to give the anti-supplement zealots some gigantic number of “adverse events” to scream about.”

    Isn’t that what’s done with drugs? If so, maybe the numbers would balance out the anti-drug zealots who constantly scream about “adverse events” attributed to approved drugs. If so, that will help establish an equal playing field.

    Another reason to do it is to try to prevent manufacturers from failing to report serious AEs by claiming that they didn’t sound serious. I was once forwarded a email from companies telling person who told them that she had gotten argyria, gray skin, from their silver supplement not to even go see a doctor. Others have simply responded that that couldn’t possibly be true because their silver supplement can’t possibly cause argyria.

    Now please don’t tell me again that silver supplements are snake oil and not dietary supplements because the law and the supplement industry disagrees with you on that.

  20. Sir Eccles says:

    Suggest new name for the supplement industry:

    “Big floor sweepings”

  21. rosemary says:

    Cervantes, I follow one supplement very closely, silver. It has disfigured many people and there are doctors in Canada who have attributed a death to it. While it is possible that they are correct, I don’t think the evidence is anywhere near conclusive, but there is no doubt about the disfigurement. Many cases have been reported in the med. lit. and others have sent me their medical records and biopsy reports.

    I am also aware of very serious injuries and deaths caused by other supplements.

    There are several problems involved in trying to determine the safety of substances, especially those marketed as natural and food, which are not adequately tested before being marketed. Some who are injured never think that perhaps it was the supplement that caused the injury. Others are so embarrassed because they believed such false and incredible claims that they blame themselves and won’t speak out, and those who do approach an attorney find it hard to find one to represent them because the supplement companies responsible don’t have funds they can find to pay if a judgment is reached.

  22. SD says:

    Ah, Cde. Gorski. At it again, I see.

    Above and beyond a criticism of your loathsome bloviations on the general topic of how excellent it is that other people are in danger of being managed more to your liking, I note several falsehoods and follies in your post. We’ll take my view on your practices and beliefs (“loathsome, iniquitous, beyond the realm of civilized or rational thought”) as a given, as well as your rationalizations for them, and skip directly to the tastiest meat of the matter.

    The most glaring outright falsehood is to be found here:

    “I’m not a politician, nor am I a political blogger.”

    Yes, you are, Comrade Gorski. You regularly extol the virtues of the political process when it works in your favor, and cavil against it when it does not. Do not lie. Your every post on this site is meant to have a “political” effect, namely the extinction of your enemies by political fiat. To say otherwise is disingenuous.

    In fact, it is belied by this later quote:

    “Even so, the McCain-Dorgan bill strikes me as unlikely to pass unless there is a groundswell of public support for it, which is why I hope you will contact your Senators and tell them you support the bill and hope that they will support it too.”

    Asking for people to contact their representatives and request a favorable vote on this bill is a political act, Comrade. Speak truth. That’s a “sciency” thing to do, you know.

    The folly more or less permeates this post.

    Let’s start with the economic.

    (*) Regulation has several effects. One well-known effect is that it increases average operating costs for industry participants. Otherwise, the regulation doesn’t *do* anything.

    Another effect is that it reduces the number of industry participants. Again, if this does not happen, then the regulation accomplished nothing more than spending tax money for no net effect.

    When we add these two effects, the structure of a freshly-regulated industry is clear – fewer and larger participants – generally proportional to the cost and scope of the regulation. This is so because the effect of such regulation is to drive marginal producers out of the market, leaving larger, established concerns, which are better able to absorb the costs of regulation. These larger producers get larger still, owing to the fact that they profit mightily from increased per-supplier demand. Large business interests *love* regulation, because it has a wonderful way of depriving them of competitors. Econ 101, dude. Learn it. Love it. Live it.

    In fact, you bring this quote up here, demonstrating this process perfectly:

    “Even more Orwellian, the CRN actually claimed with (apparently) a straight face that the supplement industry had lobbied to “increase the regulation under which the supplement industry operates” and to “increase funding for the FDA’s enforcement efforts.””

    Question for the Comrade (ignoring the question of *whether* it’s any of your goddamned business at all): is it better for the SBMistas to deal with (a) a large number of small suppliers, or (b) a small number of very large suppliers?

    That one’s probably too tough.

    (*) Okay, here’s another one that will blow your mind. Ready?

    Two words: “regulatory capture”. Right now, supplement manufacturers do not get a say in what the FDA does. That’s because they and the FDA operate in different spheres, so to speak. Civics lesson: it is considered “fair” to give the subject of regulation a seat at the table. We do it all the time. Now, this will give Cde. Gorski heartburn – *chuckle* – but given how apoplectic y’all get over things like NCCAM, *just* *wait* until you get a “National Supplements Board” shoved up your collective ungreased assholes. Do you really, seriously, in the face of all evidence to the contrary, think that that *can’t* or *won’t* happen? I have a bridge to sell you, then. Beautiful view of the Manhattan skyline, too.

    (Was your mind just blown? That’s right, that *just* happened. Well, I warned you.)

    Okay, let’s move on to political folly.

    (*) If you think that two senators in the pay of Big Supp (or whatever other sobriquet you customarily give the supplement industry) is bad, just wait until 42 of them are in the pay of it owing to the dot-product of “regulatory capture”, “market share increase”, “increased defensive lobbying”, and “(mistaken) customer perception of increased safety owing to increased regulation”. If you think it’s difficult to kill *now*, wait until it becomes a client of the regulatory state. You’ll *NEVER* get rid of it.

    (*) Wonder why lots of those supplement companies are in Utah? That’s because supplement use has a distinct *religious* dimension to it. Mormons in particular are very big on supplement use. I believe that other denominations that eschew medical intervention, specifically Jehovah’s Witnesses and Christian Scientists, are also big on supplementation. Whatever your view of those religions is, I can guarantee you one thing – you *will not* win a fight with them. Period. You may as well get used to that idea.

    (*) As a context-free observation, the use of dietary supplements involves individual people doing something that they perceive to be (and, evidence suggests, *is*) safe when not taken to extremes. As another context-free observation, people do not like to be told what to do, particularly if they cannot see or do not believe that anyone else is harmed thereby. Cheering the extermination of your political enemies is all well and good – truth be told, I expect no more of you than lukewarm schadenfreude, Comrade, and you never disappoint – but in so doing you run the risk of destroying what miniscule political capital you’ve managed to hoard against your political enemies’ onslaught. Rather than do the – *ahem* – SCIENCE necessary to demonstrate “X is bad” or “X is good”, where X is whatever supplement-du-jour exists out there, and permit people to make their own decisions about what to do with, I say again, *their* *own* *bodies*, *WITHOUT* your intervention, based on that information, you cheer the formation of new bureaucracies and new regulations whose sole purpose is to impose your will on the general populace.

    This works – for awhile. The failure modes of such a system are not pleasant, though, and its architects tend to wind up in very uncomfortable positions. Using or supporting the use of political power to do things to other people that they neither asked for, nor desire, nor appreciate – rather than taking the moral high road of *convincing* them to do those things of their own free will and permitting the outliers their freedom, however ill-advised – does not work out well in the long term. I urge strongly against it. This recommendation will have no effect on your actions, of course – you’re too deep in your iniquities for that, I fear – but hope does, indeed, spring eternal.

    “whistlin’ la marsellaise”
    -SD

  23. stewiegriffin81 says:

    Jeff said “But it is worth pointing out how safe legal supplements actually are. The American Association of Poison Control Centers just released their annual report for 2008. During all of that year the AAPCC received only 1,205 moderate, and just 65 serious Adverse Event Reports for all catagories of dietary supplements. There were no deaths.”

    This is simply not an adequate way of determining whether or not a supplement is safe. There is already good evidence that some supplements are dangerous, and they are of course not being reported. After all, why would they? Unless a supplement caused a clear and obvious death/condition very closely temporally related to the ingestion of the supplement, no one would think to consider that a supplement was the cause (or, at the very least, a contributor) of someone’s death/condition.

    You may want to read this paper:

    Bjelakov, et al (2007). “Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention: Systematic Review and Meta-analysis”. JAMA. 297: 842-857.

    What it shows is that there is a statistically increased risk of death from taking either beta-carotene, vitamin A, or vitamin E. The increased risk is very small, but it is there. Some legal supplements are clearly dangerous.

  24. David Gorski says:

    Cheering the extermination of your political enemies is all well and good …

    Such over the top rhetoric and SD wonders why I no longer take him seriously and now consider him no more than a troll. His “comrade” schtick–and, make no mistake, schtick it is–has long ago jumped the shark from being occasionally mildly amusing to being nothing more than tiresome. Oh, well. I suppose I should be thankful for small favors in that, as far as I can remember, SD hasn’t (yet) added Nazi allusions to his Stalinist and Maoist allusions, although the reference to “extermination” may well portend the addition of Godwin-worthy antics to his usual repertoire.

  25. SD says:

    “Such over the top rhetoric and SD wonders why I no longer take him seriously and now consider him no more than a troll. His “comrade” schtick–and, make no mistake, schtick it is–has long ago jumped the shark from being occasionally mildly amusing to being nothing more than tiresome. Oh, well. I suppose I should be thankful for small favors in that, as far as I can remember, SD hasn’t (yet) added Nazi allusions to his Stalinist and Maoist allusions, although the reference to “extermination” may well portend the addition of Godwin-worthy antics to his usual repertoire.”

    I think you meant to write this:

    “I have never taken SD seriously, because I am deeply wed to my ideology. I call him a troll because it is a convenient thought-terminating cliche, releasing me from any need to analyze what he is saying to me. I am perpetually offended by the fact that he does not permit me to euphemize my philosophy of medical Bolshevism, preferring instead to unceasingly call things by their real names in a manner which is not flattering to my position even though it is absolutely accurate. At the moment, my butthole is sore because the points he brought up are things that I hadn’t even considered when I spouted off about the Joys of Regulation. Maybe if I invoke Godwin, he will draw back in fear of losing Internet Points and I can save face.”

    There, I fixed that for you.

    I’ll make you a deal, Comrade – you stop espousing a philosophy of untrammeled medical Bolshevism, and I’ll stop calling you “Comrade”.

    Yes, you do secretly wish for the extermination (“complete destruction”) of your political enemies, and regularly support policies that you *believe* to further that goal. Leaving to the side for the moment the question of whether or not that is your right or consonant with justice (it’s not), I have attacked the question of *whether* this event will actually accomplish said goal. The simple truth is, it will not. Rather than crying to Mom about what a troll I am, I suggest a salutory utterance instead:

    Cde. Gorski: “You know, I think I might have screwed the pooch there just a l’il bit. I got so caught up in the moment, so thrilled that my hated enemies were going to get the shaft, that there were a few things I just completely forgot to consider. In retrospect, maybe this isn’t quite the good idea I thought it was. There are better ways to accomplish my goals. Thank you, SD, for pointing out those flaws. The scientist in me rejoices at the correction of Error.”

    So how about it, Comrade? I assure you, there are yet flaws in this regulation that you never considered and I have yet to even bring up.

    “never happen”
    -SD

  26. mikerattlesnake says:

    Ah, the Bloviating Libertarian (longwindus aynrandi), easily spotted in the wild by his elaborately worded, lengthy displays that avoid historical precedent and reasoned debate for self-congratulation, smug pseudo-cleverness, and dodgey economic theory. The displays are confusing to observers as they seem only to be self-satisfying.

    The creature also seems to have limited vision, apparently only percieving monochromatic, high contrast images. This may cause difficulty in higher level problem-solving which requires a more detailed, complex picture. Creature shows limited reasoning, but when provided with many, vastly different problems always comes up with the same solution, despite past ineffectiveness.

  27. Pingback: The SkeptVet Blog
  28. Chris says:

    Wow, what a freaking tiresome troll! All ad hominem, and not one bit of substance. Nor any real wit.

    Fortunately trolls tend to go away if you ignore them.

  29. Chris says:

    To be clear, I was referring to SD the troll. Though I do like mikerattlesnake’s response!

  30. SD says:

    @mikerattlesnake:

    So, do you have any actual objections to the points raised? (Summarized here for your convenience.)

    (*) The phenomenon of increased regulation weeding smaller competitors out of the market, leading to entrenched larger interests.

    (*) The phenomenon of “regulatory capture”, where regulatory agencies are influenced by the industries they regulate.

    (*) The counterproductive (from your perspective) nature of the regulatory State creating a clientele with increased influence.

    (*) The correlation of religious anti-medical movements with supplement usage, their refractory nature to regulations which disproportionately target them, and the inadvisability of promoting such regulation given their influence.

    (*) The growing disinclination of an increasing percentage of the general public to countenance further restrictions on their personal behavior when it does not harm someone else, and cannot be shown even to harm *themselves* in a clear and convincing manner.

    I’ll even throw in a couple more points to consider for free:

    (*) The potential “credibility gap” if such restrictions are actually enacted and life expectancy, morbidity, or other health statistics demonstrate decline afterwards *for whatever reason*. “Correlation is not causation!” and “‘Post hoc, ergo propter hoc’ fallacy!” does not cut much ice with the public, son. Doesn’t cut *any* ice, for that matter. Summary of principle: When you set yourself up as Pharaoh, commander of all things, to be credited as the source of all benefits, be prepared also to accept the blame for all misfortunes.

    (*) The potential “credibility gap” among members of the medical profession with respect to the SBMistas. The majority of the medical establishment has little use for SBM and sees it as a fringe movement; as a member of what is styled another “fringe”, I can tell you that one sure way to be ignored is to fight stupid and pointless battles. (I have a problem with the libertarians chanting “Abolish the Post Office!” for the same reason; yes, it’s a good idea; no, it does not gain much ground with the general public, because the ‘wacky factor’ kicks in and ears begin to slam shut. There are better targets.) The average doctor sees no reason at all to outlaw or unduly regulate supplements; it is easier for the doctor to say “Go to the store and buy a bottle of calcium capsules” than it is to write a prescription for calcium carbonate USP and keep refilling it every month. I will wager that most of them don’t see the harm in supplements and do not consider the current evidence to be sufficiently compelling to advise either for or against; they seem, mostly, to not care about the supplements unless they are obviously interfering with a particular treatment they prescribed. Increasing doctors’ workload by forcing them to be the “gatekeepers” for what supplements are still “permitted”, and painting them with big bulls-eyes as “the reason Joe Public can’t get valerian root any more”, is not going to earn you a big “Thank You” from this critical constituency that you ostensibly hope to convince.

    I expect little more than yap from you, of course – the denizens of this blog excel at snarky soundbites, not substance – but I’ll throw it out there for consideration.

    “jes’ chummin’”
    -SD

  31. Peter Lipson says:

    This uber-libertarian shtick is pretty boring. It’s no different from any of the altmed cults, full of assertions unsupported by anything other than ideology. For example:

    (*) The correlation of religious anti-medical movements with supplement usage, their refractory nature to regulations which disproportionately target them, and the inadvisability of promoting such regulation given their influence.

    First, there is no data given in re regulation having no effect. Second, it’s actually a straw man. I have no idea whether more robust regulation will change the hearts of cultists, but I have confidence that it will reduce the unsupported claims of the supplement makers and perhaps reduce the inappropriate marketing and use of these nostrums.

  32. David Gorski says:

    This uber-libertarian shtick is pretty boring. It’s no different from any of the altmed cults, full of assertions unsupported by anything other than ideology.

    Yep, particularly when combined with the implication that anyone who doesn’t agree with him must be a Communist or Socialist (i.e., the whole “comrade ” schtick).

  33. SD says:

    “This uber-libertarian shtick is pretty boring. It’s no different from any of the altmed cults, full of assertions unsupported by anything other than ideology. For example:”

    Actually, for a group so a-tic over “prior probability” (codeword, in the way it is used here, for “things we bellyfeel”), you should *love* hard-core libertarian theory (particularly of the Austrian/Misesian/Rothbardian tradition); it offers assertions supported by iron-clad chains of inference from what are essentially inarguable axioms, like “Individuals own themselves” and “Humans act”. That you don’t like the conclusions they reach is, frankly, a personal problem, and not a flaw in the logic.

    Seriously – I recommend picking up a copy of “Human Action” and reading through it. If you can restrain *your* ideology, you might well walk away from the experience with a better understanding of how classical economists and libertarians think.

    ” (*) The correlation of religious anti-medical movements with supplement usage, their refractory nature to regulations which disproportionately target them, and the inadvisability of promoting such regulation given their influence.

    First, there is no data given in re regulation having no effect.”

    You’ve never witnessed a hard-core Jesus-freak getting his back up over a perceived infringement by the government of his religious rights, or a perceived attack on his religion?

    What planet do you live on?

    Side note: this provides the seeds of what we call a “black market”. (Another of those “side effects of regulation” you learn about in Econ 101 – reducing supply or increasing price by fiat does not imply an automatic shrinking of demand. Example, the War on Drugs. Example, pharmaceutical counterfeiting. QED, I win. If you are concerned with quality problems in the market as it exists now, I assure you that they will only get worse in a black market.)

    “Second, it’s actually a straw man. I have no idea whether more robust regulation will change the hearts of cultists,”

    That’s the spirit. Really let ‘em know what you think of ‘em. Give it to ‘em in the keester but good. *That’ll* show ‘em.

    “but I have confidence that it will reduce the unsupported claims of the supplement makers and perhaps reduce the inappropriate marketing and use of these nostrums.”

    Okay, *WHAT* unsupported claims? The amusingly-snarkily-named “Quack Miranda”, i.e. “This product does not claim to treat or cure any disease?” “This product has not been evaluated by the FDA?” F’fuxakes, it’s written *right on the bottle*. It’s *right* *there*. In plain English. On the ads, too. Is it your contention that people are too stupid to read, and “need” your help to navigate the world?

    What level of agency is the average citizen to be posited to have, in your estimation?

    Question: Would you be happy if the same supplements were sold today, as freely as they are today, but with no markings or marketing of any kind other than “type”, “dosage”, “certified list of ingredients”, “certifying agency”, and “count”? Would *that* satisfy you?

    “master of the gom jabbar”
    -SD

  34. Peter Lipson says:

    master of the gom jabbar

    HAHAHAHAHA!!!

  35. SD says:

    Govorit’ Cde. Gorski:

    “This uber-libertarian shtick is pretty boring. It’s no different from any of the altmed cults, full of assertions unsupported by anything other than ideology.

    Yep, particularly when combined with the implication that anyone who doesn’t agree with him must be a Communist or Socialist (i.e., the whole “comrade ” schtick).”

    Not ‘anyone’ who doesn’t agree with me, no. You, certainly. There are patterns of disagreement and word-usages that imply particular mindsets. You pattern-match as a lukewarm reflexive Fabian Socialist, with very few deviations from the predictable. You take it as an article of faith that you – by right and privilege – have and *should* have the authority to decide certain things for other people, because they don’t “do it right” for themselves, and therefore their options must be limited to only “right” choices. You also view these actions through a “social utility” lens rather than a “individual rights” lens, leading you to conclusions whose implementation infringes individual rights in favor of your “optimal” Benthamite outcome.

    Case in point: supplement use. I do not argue that supplements are a priori a “good idea”. I don’t care. Some people make supplements. Some people take supplements. Since neither of those is me (other than a multivitamin), and since I do not possess the right to mind other people’s business for them, I ignore the business. Caveat emptor. If someone asks my opinion, I’ll tell ‘em; otherwise, their job is to run their own life as they see fit, and to leave me alone to do the same. This extends to the manufacturers; they make what people *want*. If nobody wanted supplements, I can guarantee you it wouldn’t be a multibillion-dollar industry. That demand – that *desire* – is not going to go away just because you think it ought.

    Further, legislation to “regulate” supplement manufacturing is unnecessary, owing to the fact that (a) they print their disclaimer right on the bottle, and (b) there are already laws against selling adulterated products (a species of fraud, “this does not contain what you said it contains”). There exist independent certification laboratories – hell, the *NSF* certifies supplements – and quality-control systems for ensuring the use of good production processes. *as well as* a natural incentive on the part of the producers to not sell bogus products, owing to the size of this field and the number of competitors involved in it. (If Producer A is caught doing the Chinese milk shuffle on their production line, then Producer B – flogger of an identical substitute – is exactly one shelf to the left, and Producer C’s wunderpill right next to it.) Are there failures? Yes. Are there failures in the FDA’s processes, or in government regulatory processes as a whole?

    Go ahead, tell me “no”, I need a good laugh.

    The only reason increased regulation is “needed”, from your perspective, is that anything even vaguely medical in nature “needs” to be *supervised*, in your opinion, by you or those who share your mindset. While I certainly understand that urge – and I will be charitable here and ignore the obvious “profit” aspects of that arrangement – I suggest you contain it, because folly and madness lie at that road’s end. Most of that folly and madness is well-mapped, and I have pointed it out above; regulation does *not do* what you think it does. (Think of it like a really nasty drug with lots of side effects – maybe one of the TB-treating arsenicals.)

    If you are concerned about supplement quality, then the best thing you could do would be to get a chromatography column, buy some samples from your local store, and publish the test results. Do this on a regular basis. Offer a trademark to the supplement manufacturers to glue on their bottle. Build a name that means “quality”.

    If you’re concerned about supplement *safety*, then provide a collection point for information about various supplements actually *do* and at what dosage. Set up your own adverse-event reporting system. Sell cheap laser-printed and laminated information books to Kroger’s and Safeway. Build a name that means “authoritative”.

    If you would like to create tomorrow’s headache – for you and everybody else, above and beyond the question of whether it is right for you to do it anyway – then yeah, keep cheering for the legislation and do your best to get it passed. When you are complaining about how the FDA is not doing what you want them to do because Big Supp now owns the Supplement Control Board, in addition to the manifold *other* pathologies of regulation (black markets, monopoly creation, quality decline, &c.) that will manifest themselves, drop me a line and I’ll be ever so happy to remind you that I told you so.

    “nothing for nothing”
    -SD

  36. Jurjen S. says:

    Didn’t I correct your Russian a while back, SD? And by way, (mis)taking someone of Polish descent for a Russian is culturally insensitive, to say the least.

  37. BillyJoe says:

    It’s not so bad when someone’s ideas end up sounding like ideology but, when someone lets ideology drive the totality of their ideas, you have to give up and walk away because discussion is impossible.

  38. mikerattlesnake says:

    “it offers assertions supported by iron-clad chains of inference from what are essentially inarguable axioms”

    That this is your standard of evidence for your beliefs speaks volumes.

  39. Composer99 says:

    SD is indeed a troll.

    To whit:

    - He offers up assertions without evidence, save the occasional anecdote (e.g. the ‘Jesus freak’ comment). Several references are made to ‘Econ 101′ without citing a basic economics textbook or other introductory source to which we may refer.

    - He appears to argue that since the proposed regulation can never be perfect, it must never be implemented. This is a form of Nirvana fallacy: the good must be discarded because it cannot be perfect (although I assume SD would reflexively disagree with almost any regulation being ‘good’).

    - Instead of offering evidence in his favour, he demands that others provide evidence to contradict him (per his reply to mikerattlesnake). This is immoral. It is his responsibility to prove he is right, and without evidence, we have no reason to take him at his word.

    - He erects a straw man of Dr Gorski’s argument and uses it to call Dr Gorski a Communist.

    - He erects a straw man of ‘prior probability’. Prior probability in science-based medicine is derived from the evidence base of the basic sciences and previous medical research. Apparently actual data, in SD’s knowledge universe, is equivalent to unsubstantiated assertion.

  40. rosemary says:

    You know if a law is passed requiring that all supps list all ingredients they contain on their labels and if that means all the ingredients detectable by chemical analysis and if consumers actually read the labels, that may very well mean that homeo products are relegated once more to the lunatic fringe segment of the market with whom they’ve hibernated under dead logs for years.

    Yes. I know there are a lot of ifs and as long as homeo products sit next to the OTCs on pharmacy shelves, I don’t know how many consumers will read the ingredients listed on their labels, but I am quite certain that the reason they’ve taken off in the mainstream market place is because the way they are sold leads consumers to mistake them for OTCs rather than well shaken water.

    Then of course there is the other problem in that not all products which label themselves as homeo actually are classical homeopathic “remedies”. Some actually do contain detectable levels of pharmacologically or toxicologically active ingredients.

  41. “iron-clad chains of inference”

    Classic.

  42. rfrancis1980 says:

    SD is right on this, you guys should listen to him.

    Perhaps the barbs and jabs intermixed with his rational, logical, thoughts and ideas are making that impossible for you guys or perhaps his ideas about individual liberty are so incomprehensible to you guys.

    What SD is really referring to, and I learned this the hard way, is codependency.

    Just like people land some where on the left – right spectrum, the kinsey scale, the IQ scale, etc, people lie some where along the codependence – independence scale which in many ways is a communist – libertarian scale.

    The medical profession amongst all other professions has one of the highest rates of codependency where doctors, nurses, psychologists, etc, have a desire to be needed by others and in turn need others themselves. Such desires result in symptoms like a desire to make choices for other people because these other people are not wise enough to make the best choices themselves.

    None of you, NONE OF YOU, addressed his points on the removal of individual liberty such supplement regulation would result in. You guys are oblivious or do not care.

    We only need to look at surveys that show half the population thinks we have too much freedom of speech to see that people don’t really believe in the concept nor the individual liberty that underlies it.

    The desire to control others exists the world over and it rears its ugly head in a variety of ways. It is the principle reason there is so much conflict in the world.

    SD isn’t a troll. SD educates, informs, and insults which is more than I can say for those who replied to him who made with the insults and nothing else.

    P.S. Yes I take supplements, it’s how I found this article and site, I take Super B Complex, vitamin C, grape seed extract, and Omega 3 fish oil on a regular basis in addition to a multivitamin and no I do not want the damn govt interceding to stop me. It may be anecdotal but my cholesterol last time it was checked was 110 and I eat kielbasa dogs and cheeseburgers almost every night.

  43. Chris says:

    So how are children supposed to make an informed decision when their parents push Boyd Haleys “OSR” on them? What part of it being an industrial chelator did you miss?

    I sincerely doubt you would lose access to real vitamins, fish oil and the like. The real issue is when someone bypasses the drug regulatory process and decided to randomly call a very un-natural chemical a “supplement.”

    Then there is the factor in using various herbal concoctions that have very real, and sometimes very dangerous side effects. I actually know of several lovely plants growing nearby that I can pick and create a tea or tincture from that would cause your body some grievous harm (and actually some folks here have ended up in hospitals, and sometimes requiring liver transplants due to thinking these plants were safe). If we had it SD’s way, I would be perfectly free to package and sell my very special “tea.” The book, Natural Causes, there are stories about deaths from those special teas (one was the wife a lawyer, who now campaigns against DSHEA!).

    So Boyd Haley’s very special “tea” is that OSR. You really need to tell me why it is a good thing that he is selling it to desparate parents.

  44. Chris says:

    Also I am married to someone whose father was from Holland. He also eats lots of cheese, sausage and butter (their family recipes seem to include braising meat in a pool of butter). His cholesterol level is also very low. That is called genetics.

  45. Todd W. says:

    Two words sum up SD and rfrancis1980′s position: Buyer beware.

    They appear to believe that every person should be able to do whatever the hell they want, and that it is up to the consumer to be informed and capable enough to not be taken for a ride. In other words, if someone gets harmed, it’s their own damn fault.

    It’s a very callous viewpoint. All for making money at the expense of suckers.

  46. Geekoid says:

    rfrancis1980 -
    “None of you, NONE OF YOU, addressed his points on the removal of individual liberty such supplement regulation would result in. ”

    That’s because it’s an ignorant point and only deserve ridicule.

    We had supplements when they were previously regulated, and this regulation only hold the people making them accountable. It in NO WAY will reduce that availability of supplements.

    Here is some education for you:
    http://www.urbandictionary.com/define.php?term=troll

    Yes he is a troll, and you are now his tool. Well done.
    Assuming your not the same person.

  47. pmoran says:

    rfrancis1980: “SD is right on this, you guys should listen to him.”

    Why?

    He seems to interpret any kind of regulation of supplements as an infringement of the individual’s right of choice, yet claims the proposed changes to DSHEA aren’t needed because of the disclaimers that are already present on supplement products. How come? is this not because of present *regulations*?

    He claims measures against adulteration aren’t needed because there are ‘already laws against selling adulterated products (a species of fraud, “this does not contain what you said it contains)”’

    So one can be sympathetic to his argument about personal rights, and also the possibility of unexpected consequences from imposing more regulation (ignoring the real problems of NOT taking action) but point out that even he recognizes the worth of placing some limits on those seeking to profit from those rights.

    I haven’t looked at the new bill but doubt if it will stop you doing what you want.

  48. Chris says:

    Todd W.:

    Two words sum up SD and rfrancis1980’s position: Buyer beware.

    I wonder if I could offer them some tea? Perhaps they would like some of my stew with herbs? (I actually know what I pick!)

  49. Jeff says:

    We had supplements when they were previously regulated, and this regulation only hold the people making them accountable. It in NO WAY will reduce that availability of supplements.

    This statement is not correct. From the ANH website:

    “DSSA would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.

    If this bill passes, the FDA would have full discretion and power to compile a discreet list of supplements allowed to remain on the market. Supplements drawn entirely from food and long established supplements or supplement potencies could be arbitrarily banned.”

    Do you want some FDA bureaucrat deciding what supplements, in what potencies, you have access to? The main purpose of this new bill is to restrict access to supplements under the pretense of “supplement safety”.

    Geekoid, you can read a summation of arguments against McCain’s bill here:
    http://www.lef.org/featured-articles/Dietary-Supplement-Safety-Act-of-2010.htm?source=eNewsLetter2010Wk7-1&key=keep_reading

  50. SD says:

    @Composer99:

    “SD is indeed a troll.”

    Ah, another voice from the Collective, denouncing me.

    Do y’all *suppose* you could take a stab at thinking of this economically and phrasing things in those terms? The effort might do you good.

    “To whit:

    - He offers up assertions without evidence, save the occasional anecdote (e.g. the ‘Jesus freak’ comment).”

    That one falls into the “everybody knows” category. Religious people do not like it when you fuck with their practices. No, I do not argue that supplement use is a sacrament of ay religion; however, for religions which are dubious of or antithetical to modern medicine, these represent a sort of “self-treatment” option that they avail themselves of, and depriving them of it by political fiat is not going to go over well. I suppose I’m stumped; what part of that is either (a) difficult to understand, or (b) not immediately prima-facie believeable?

    “Several references are made to ‘Econ 101′ without citing a basic economics textbook or other introductory source to which we may refer.”

    That’s because I’m assuming that you either (a) have an Economics 101 textbook that you never read in your life, and/or (b) know where to find one. It’s not difficult. Even the obnoxiously half-assed courses in economics being taught at campuses for the last twenty years include sections on things like “Unintended consequences of regulation”.

    If you would like to know more, I cited one book: “Human Action”, 3rd or 4th ed., Ludwig von Mises. You can even read it for free.

    Here’s a few more:

    “Bureaucracy”, Ludwig von Mises.
    “The Road to Serfdom”, Friedrich von Hayek.
    “Economics in One Lesson”, Henry Hazlitt.
    “That which is seen, and that which is unseen”, Frederic Bastiat.

    There are a lot more that cover topics like regulation, but these suffice for a start. At least three of these books are available online for free. I encourage you to find them yourself, and make the effort to understand them. “Economics in One Lesson” in particular, as well as Bastiat, are good reads for understanding some of the unintended consequences of regulation and how they come about. As I noted before, given the givens, you cannot argue the results. If you’ve no background in advanced math or symbolic logic, that standard of proof might be somewhat foreign to you, but believe me, it *does* exist.

    “- He appears to argue that since the proposed regulation can never be perfect, it must never be implemented. This is a form of Nirvana fallacy: the good must be discarded because it cannot be perfect (although I assume SD would reflexively disagree with almost any regulation being ‘good’).”

    This is not a case of “the perfect being the enemy of the good”; it is a case of “the bad being a really stupid idea, and uncritically-examined to boot”. Cde. Gorski was so busy having gushing orgasms over the possibility of legislating and/or regulating his hated enemies out of existence that he apparently did not consider the idea that regulation doesn’t necessarily do what you think it does.

    Like I said, the cure for “supplement quality problems” is a chromatography column. The cure for “supplement usage problems” is a series of studies and a laser-printer. The cure for neither involves a hundred pages of law in the Federal Register.

    “- Instead of offering evidence in his favour, he demands that others provide evidence to contradict him (per his reply to mikerattlesnake). This is immoral. It is his responsibility to prove he is right, and without evidence, we have no reason to take him at his word.”

    Mmm, no, I demand that people address the points raised. I admit to some digression on my own part – I had intended to restrict this to the discussion of “economic fact”, not “natural rights”. I slipped. Sorry. In my defense, when confronted by the eerie polyphonic Borg-like voices of the denizens of the blog I like to refer to as “Savagely Bolshevized Medicine”, performing the amusing vocal trick of denouncing me while visibly fellating each other about how awesome their posts are, I lost sight of my main goal. My apologies. I shall endeavor to keep it from happening again.

    As far as evidence, I guess I don’t see the need to provide any, since it is a priori obvious, even by reference to current events (which, again, I assume that “everybody knows”). Do you deny the existence of such a phenomenon as “regulatory capture”? Do you deny that regulations on suppliers either drive up the costs for suppliers, or accomplish nothing? (There isn’t really a “third choice”, there.) Do you deny that regulations on suppliers drive marginal producers (“marginal” == “producers operating at or near the level at which the business becomes unprofitable”) out of the market, or accomplish nothing? (Again, no third choice.) What, exactly, do you have a problem with here?

    “- He erects a straw man of Dr Gorski’s argument and uses it to call Dr Gorski a Communist.”

    No, I said that he pattern-matches as a lukewarm reflexive Fabian Socialist. I can explain those terms in detail, but would rather you just look them up; my usage does not differ from their individual standard meanings. When you do, you can tell me where Cde. Gorski’s stated positions to date differ meaningfully from the positions espoused by an archetypical l.r.f.S. So far, I haven’t seen any deviations.

    Unlike you, I operate from observation. I observe that Cde. Gorski’s behaviors mimic those of someone of a particular political persuasion. This observation has predictive power, since given a particular development, I can predict how Cde. Gorski will respond to it before he actually does. I calls ‘em like I sees ‘em, in other words.

    Sometimes A is A, dude.

    “- He erects a straw man of ‘prior probability’. Prior probability in science-based medicine is derived from the evidence base of the basic sciences and previous medical research. Apparently actual data, in SD’s knowledge universe, is equivalent to unsubstantiated assertion.”

    Mmm, no. Prior probability is a term derived from Bayesian statistics. Its usage in the context of medicine is suspect. Its usage by Cde. Gorski is *particularly* suspect, since he desires to use “prior probability” – in other words, “what appears to be plausible *to me*” – as a precondition for even *studying* certain treatments, or accepting the results of a study regardless the correctness of its methodology, a usage WELL out of the realm of rationality given the nature of the human population and the reality of what that number actually represents. My guess is that this stems from a sadly typical misunderstanding on the part of a majority of MDs (guess: >99%) of the actual mechanics, methods, and utility of statistical inference, but that’s a discussion for another place and time.

    Suffice it to say that one hears the words “prior probability” coming out of Comrade Gorski’s mouth, it is safe to replace that term with “studies I like”.

    “none so blind”
    -SD

  51. Composer99 says:

    rfrancis1980: If SD is going to post very long diatribes, offer up unsubstantiated assertions as established fact while simultaneously failing to back them up, call people Communists based on (deliberate?) misinterpretations of their positions, and then reverse the logical burden of proof (in his knowledge universe, it is apparently up to others to prove him wrong instead of up to him to show others why he is right), then we can conclude he is a troll.

    It is easy – perhaps even facile – to simply insist that consumers operate under ‘caveat emptor’. For a good summary of why this may not be a good idea, might I recommend you read a book such as ‘Risk: The Science and Politics of Fear’ (published in the US as ‘The Science of Fear’) by Dan Gardner (http://dangardner.ca/), which explains how we are coming to realize that rational, critical thinking – the most reliable tool for evaluating health claims by supplement manufacturers – is not something people come to naturally, nor is it an easy skill to learn or master.

    Besides, in a way, telling consumers that it is their responsibility to sort out which health claims are real and which are bogus seems like basically the same philosophical malpractice (so to speak) that SD gets up to on this blog: putting the burden of proof on the wrong person. The burden of proving that their products are (a) safe and (b) efficacious rightly ought to be on the shoulders of the people selling them (this is what warranties/guarantees are for), not on those of potential buyers. To reverse the burden of proof is to condone the violation of the buyers’ property rights by unjustly exposing them to fraud.

  52. Composer99 says:

    Wow. That didn’t get moderated due to the link. Lucky me.

  53. SD says:

    @composer99:

    “It is easy – perhaps even facile – to simply insist that consumers operate under ‘caveat emptor’. For a good summary of why this may not be a good idea, might I recommend you read a book such as ‘Risk: The Science and Politics of Fear’ (published in the US as ‘The Science of Fear’) by Dan Gardner (http://dangardner.ca/), which explains how we are coming to realize that rational, critical thinking – the most reliable tool for evaluating health claims by supplement manufacturers – is not something people come to naturally, nor is it an easy skill to learn or master.”

    Are you arguing, then, that once diagnosed with a ‘serious’ disease, that the effect on ‘rational, critical thinking’ is so severe that a patient no longer has the capacity to choose a treatment? Do you argue that therefore their treatment choices must be made for them? If not, why not?

    The term for someone incapable of making their own choices is ‘ward’. Are patients to be wards of their doctors? Arguably, the doctor is more capable of making the ‘right’ choice than the patient is, particularly under such conditions of duress, as you style it. Is the relationship between patient and doctor to be reminiscent of that between an indentured servant and a master?

    Do patients have the right to cease participating in treatment for whatever reason they choose? For *any* reason they choose? Why? Can the doctor decide that *for* the patient? Why not, if the patient is not ‘rational’?

    If you are not willing to argue that patients diagnosed with a serious disease are incompetent to determine the course and duration of their own treatment, and accept the consequences of that argument – bearing in mind that this a population under severe stress and ostensibly uniquely susceptible to woo – then by what argument do you claim that every member of the general population is incompetent to evaluate such claims accurately?

    You have stepped in an ethical minefield here. I suggest you retrace your steps and back out slowly.

    “caveat perambulator”
    -SD

  54. SD says:

    “SD is right on this, you guys should listen to him.”

    *chuckle* Save your breath, dude. Here at Savagely Bolshevized Medicine, the posters consist of:

    (a) the High Commissars of the Medical Ministry of the Politburo (Cde. Gorski et al.)
    (b) their sycophantic yes-men, who hope to be anointed with the semen of a High Commissar and thus ascend to the Outer Party (seen in the comments; their comments are essentially always semantically equivalent to “You GO, girl!”)
    (c) altmed nutbars who are just plain goofy, who come to get smacked around on a regular basis by the SBMistas (I feel bad for them; from the sidelines, it looks like Darth Maul kicking the crap out of Jerry’s Kids, they’re *that* retarded)
    (d) a handful of semi-scientific cranks that usually fall at least partly into category (b)
    (e) the occasional libertarian (who, sadly, usually enjoy a fate similar to those in (c))

    - and -

    (f) me.

    I don’t post regularly – mostly I just curl my lip up at the latest masturpieces of science-fiction, wishful-thinking, and outright Bolshevism that are posted here, it’s a guilty pleasure, a weakness, a sort of raunchy intellectual pornography that I indulge myself with on a regular basis – but every once in a while I am moved to deliver to some SBMistas (and particularly Cde. Gorski) a stiff slap to the nutsack. I suspect Cde. Gorski loves me for it, since whenever I jump into a thread, the number of posts shoots through the roof, and his retinue of sycophants have a nice enjoyable wanking session before returning to the discussion about how lame and stupid everybody else is and why they can’t just herd everybody who’s not on board with SBM into a gas chamber because they deserve it and stuff.

    It’s sort of interesting, to see the little hermetically-sealed world they live in, with a variety of intellectual ouroborii that they invoke to maintain their mental stability. You observe that none answered any of the substantive points – well, the simple truth is, *they didn’t see them*. Those words fell into a real big mental “blind spot” that these types have, and mark it well, because you see it on a daily basis. My apparently plain words morphed before their eyes into statements about how uncaring I am, how people should eat poison and die, that I don’t know science, that I hate science, screw the consumer, &c. &c. Note how I was tagged as a “Randian”, a common appellation for libertarians of the Rothbard school. (NB: Rothbard *hated* Rand, and vice versa.) I can talk all day long and none of the chorus here will acknowledge a single valid point. This is “science”, as they style it – the people they *like* are “scientific”, the people they *don’t* like are “alterna-med woo-peddling fraudicators from Hell”. The notion that perhaps they might have to answer some hard questions about their cherished shibboleths brings back memories of the time they had to cheat their way through O-chem to make it into med school, with all the psychological baggage that entails, and so they tend to fall back onto “argument from authority”, “ad hominem”, and “straw man” attacks, as well as what I will call “argument of fallacious fallacy” (i.e. calling out false fallacies supposedly invoked by the other side so as to avoid the real argument, a subtype of “straw man”) in order to make it through the thread with their worldview intact.

    Because, you know, that’s the *important* part of science – “confirming your worldview”.

    (Yes, Virginia, that was sarcasm.)

    Get me started on their epistemology sometime. That’s a *REAL* hoot.

    “None of you, NONE OF YOU, addressed his points on the removal of individual liberty such supplement regulation would result in. You guys are oblivious or do not care.”

    Long-time flame-warrior advice here: it’s that they don’t care. People do not see things that they do not wish to see, hence the ancient quote from the Bible (one that was probably lifted wholesale from graffiti scrawled on a ziggurat in Ur) – “There are none so blind as those who will not see.”

    Suggestion: Gather ye rosebuds while ye may, and ask a bunch of questions that the other guys don’t like to answer. It demonstrates for the audience (your *real* target) exactly how stewpid the opposition is.

    “SD isn’t a troll. SD educates, informs, and insults which is more than I can say for those who replied to him who made with the insults and nothing else.”

    I aim to please. >;->

    “satisfaction guaranteed or your money back”
    -SD

  55. BillyJoe says:

    “Do you argue that therefore their treatment choices must be made for them? If not, why not?”

    Unless there is nothing to choose between, the treatment of choice is already made by the treating doctor – if he is worth his salt. They can, however, refuse to take this optimal choice that has been made for them and, in their ignorance, choose one of the lesser alternatives – or no treatment at all! – if they so wish. Nobody is compelling anyone to do anything – least of all you!

    “Arguably, the doctor is more capable of making the ‘right’ choice than the patient is, particularly under such conditions of duress, as you style it.”

    That sort of kills your argument then.

    “- and -

    (f) me.”

    No, thank you, you f yourself. :D

  56. mikerattlesnake says:

    SD, you’ve continued to prove only one thing: you’re very well versed in the vocabulary of your movement. Unfortunately this seems to give you a sense of superiority (“no one else here has read as many of these libertarian economic theory books as me, therefore I must be the smartest!”), when in reality it just means you’re a very verbose blowhard.

    This site is called science-based medicine. We like positions to be backed by evidence. There is no such thing as an “ironclad axiom” and plenty of people throughout history have perpetuated extremely flawed ideas with the same premise, actual communism* being a great example. The theory of it sounds good on paper, but it ignores absolutely fundamental human traits and social trends. Just show me an unregulated, free-market economy that has not resulted in large-scale exploitation of entire classes of people and we’ll have something to talk about, OR you could just admit that you support a system that similarly exploits and then just acknowledge that we have fundamentaly different ideas about our goals for society and humanity and move on. The latter is more likely since Rand sees economic status as tantamount to societal worth, hence the lower class deserves to be exploited for the benefit of the ‘valuable’ people.

    Also, keep in mind that we are not, for the most part, ideologues. I would imagine that most people on here, like me, see value in the balance between the free market and government. Let the free market do the things it does well, and let the federal government do the things it does well. The harm in supplements isn’t in their individual toxicity (though cases of injury or death certianly don’t help their cause), but rather the errosion of people’s understanding of medicine and the standards we set. I think that health is a public concern. I don’t think the free market will solve problems with our healthcare system because I don’t think that making us healthier is necessarily profitable.

    If you’re still left wanting because we haven’t addressed your points it’s because your points are clearly educated only by your ideology and are presented with the almost laughably stereotypical internet-libertarian condescention that we have all learned to roll our eyes at and ignore. If you want to argue philosophy, you’ve clearly found an uninterested audience. If you’d like to provide some examples of where similar** regulation has ACTUALLY had the effect you mention, we will have something to discuss. As for me, I see plenty of governments around the world that mix capitalism, socialism, democracy, etc to create a relatively stable political system that I would consider close to ideal. I think it’s necessary to continue to refine that blend, not move in the other direction. I don’t know of one political system based on a pure ideology (free-market, communism, fascism, etc) that has produced what I would consider a model country.

    *as opposed to the very low bar which you set
    **make an effort to find something that is similar, please.

  57. Composer99 says:

    SD, there are two ways you could have brought forward a contrary opinion which may have generated a less chilly or scornful response:

    - You could have suggested that there were some objections to the legislation being reviewed and then enumerated them. This was done (“earlier and better” you could say) upthread.

    - You could have pointed out that all regulatory interventions (like medical interventions) have harms as well as benefits, that the harms of this particular intervention were likely to outweigh the benefits, and then outlined what you perceived were the harms. You do appear to have come close to going through this process, only without the final step (where you provide the evidence to support your argument).

    You did not do either of these. You posted long-winded rants which were only tangentially related to the DSSA under discussion. You did not back them up with evidence other than an assumption of ‘everybody knows’ (more on that later). You engaged in (and continue to engage in) what appears to be psychological projection and what is certainly baseless insult. You have (deliberately?) misinterpreted other people’s positions. And, instead of supporting your own position with evidence you have upended the burden of proof and demanded that others do your dirty work for you to disprove you – that is what you are doing by asking others to address your points despite your lack of supporting evidence.

    Based on the above, it is hard to see why anyone can be criticized as unreasonable for concluding that you are trolling or even displaying ‘crank’ behaviour.

    In particular, references to Marxism, Nazism (I noticed a gas chamber reference in there) and accusations that those who disagree with you are engaged in some sort of masturbatory ritual (I can’t think of anything less ‘sexy’ than writing on a medical blog, myself, especially when you consider how full of porn the Internet is) are pretty good signs that you are not debating in good faith.

    The fact that your ‘advice’ to rfrancis1980 is in the context of a ‘long-time flame-warrior’ does not speak well of your actual intent on commenting on this board.

    I should note with regards to my own comment that you have deliberately misinterpreted what I said. Look through my post and show me where I explicitly stated that patients who are seriously ill ought to surrender their autonomy to doctors as you suggest. Show me also where I explicitly stated that people, by virtue of not always engaging in rational thinking, are incompetent. I just read through it again and found no such claim.

    I explicitly said that rational, critical thinking does not come naturally and is not easy to learn or master. In short: it’s hard work. It takes time and effort. People do not always have the time, training, talent, or inclination to critically evaluate health claims, whether they are seriously ill, worried well, or making decisions on behalf of dependents. That is not the same as saying they are incompetent, and you know it.

    With regards to ‘everybody knows’ – well, for the longest time, ‘everybody knew’ bloodletting to balance the humours was a useful medical intervention. ‘Everybody knew’ at one point that other ethnic groups were inherently inferior, perhaps even subhuman. ‘Everybody knew’ at one point that if you got sick or bad things happened to you it was because you were somehow sinful. So I’m sure you will forgive me for not taking you at your word when your evidence is ‘everybody knows’.

  58. mikerattlesnake says:

    Also, if that post seems to be way off topic, it’s because I was mostly debating the “ironclad axiom” assertion, not the specific outcomes of that axiom. I appologize.

  59. SD says:

    Good Lord.

    Me: “The square of the length of the hypotenuse of a right triangle is equal to the sum of the squares of both legs.”

    SBM: “Nuh-uh. You didn’t cite any evidence.”

    Me: “??? Um, well, okay – if I call the hypotenuse c, and the legs a and b, then… [scribbles math on the board] Happy?”

    SBM: “No! That’s not *evidence*! What about if you use d, e, and f? Where are your studies? How do you know it’s true?”

    Me: “?!? Um, maybe we have a misunderstanding here. See, these can stand for any number…”

    SBM: “The plural of anecdote is not data! Prior probability! You’re a crank!”

    Me: “… Um, are you, like, high on drugs right now or something?”

    SBM: “AD HOMINEM! YOU’RE A TROLL!”

    It’s like an Abbott and Costello routine.

    Okay. Let’s try this again.

    We have lots of people here snarking about “evidence”. Evidence does not take the place of what we like to refer to as “logic”. I will now demonstrate.

    ASSERTION: “Regulation of suppliers in a market either raises the average cost of production for those suppliers, or does nothing.”

    ASSUMPTION: “Suppliers are greedy, i.e. are motivated by maximizing their profit margins before other concerns.”

    ASSUMPTION: “Regulation is necessary to force a ‘proper’ outcome, because it cannot occur of its own accord.”

    PROOF: Suppose that we have twenty suppliers of a good in a market, labeled A through T. The good doesn’t matter; let’s call it a widget. Better still, let’s call it “saw palmetto”, since this is all about supplements.

    Let us say further that we (the “royal we”) are concerned with quality in the market for saw palmetto, and that our goal is to improve it. Based on our cursory analysis, we associate (“associate”, because “correlation is not causation”, right?) increased use of saw palmetto with tragic cases of Peyronie’s disease, shingles, rosacea, irritability, and piles. We believe that this is due to some suppliers selling saw palmetto of insufficient quality. We therefore come up with the brilliant idea of increasing quality by regulation – we shall mandate that saw palmetto must be of a particular type, processed until 99.999% of the lots produced can be shown to be homogeneous and of the appropriate quality with a 99% CI, &c. A series of tests, in other words. You pass the tests, your saw palmetto gets to be sold to customers. You don’t, well, start looking in the ‘Help Wanted’ ads.

    This is possibly the most inoffensive use of regulation – who could be against quality? – but, as we shall see, it is not without side effects.

    Let us say that we have ranked producers A through T in terms of “product quality” – A being the highest, T being the lowest. Our regulation establishes the level of quality at one of three places:

    (a) Below the level of quality already achieved by each manufacturer, i.e. below the production quality achieved by producer T. In this case, it clearly accomplished nothing – nobody’s quality needs to improve to satisfy the regulation. The only things it managed to achieve are (1) preventing any new supplier with a quality level *lower* than the regulatory minimum from entering the market and (2) increasing the compliance burden on market particpants (though we will assume that this cost is minimal for the time being). [Side note: a regulation which achieves nothing but which still costs money to comply with and enforce is what we refer to as "stewpid".]

    (b) At the level of quality already achieved by one of manufacturers A-T. (Remember, these manufacturers are rank-ordered by “quality”, however you define it.) Let’s pick manufacturer H out of the crowd – the quality of manufacturer H is “just at” the regulatory threshold. Obviously, manufacturers A through H, exceeding or meeting this level of quality, do not have to worry – their existing production processes suffice to meet the new quality standard, and nothing needs to change. Manufacturers I through T, on the other hand, have a problem. Their manufacturing processes *by definition* do not meet this standard. That means that they will have to be reconfigured or upgraded to continue their business operations, if that is even possible. Reconfiguration and upgrades impose both opportunity and real costs to the business. Average costs have increased (some manufacturers pay nothing, some manufacturers have to upgrade).

    (c) At a level of quality *not* achieved by *any* manufacturer. Obviously, any manufacturer who wishes to remain in business has to spend money to achieve the level of quality necessary, if that is even possible.

    QED. Assertion proved. []

    See how that works? Ineluctable chain of inference. If A, then B. If B, then C. Truth table of an implication. Inarguable. Every case has been covered, along with the effects. Regulation increases costs, or does nothing; QED. Can we accept that as a “given” now, and move on? Would you like me to provide equally compelling chains of logic based on freshman-level economics for the remainder of my assertions, or would you like to grant that they are at least plausible, even if you don’t like them?

    Now, I predict that someone will, nevertheless and in the face of all reason, argue “Nuh-uh! Costs might be *lowered* because of increased efficiency! You didn’t think of that, huh, troll?” When that argument is made, I will point at the two assumptions made above – made *by y’all*, *not me* – and inquire why precisely it is that a cost-lowering increase in efficiency (which is another way of saying “profit-increasing”) innovation won’t just happen on its own *without* regulatory impetus, given that the companies are *obviously* motivated by greed. I look forward to hearing someone attempt to explain how a money-grubbing CEO will pass up a chance to increase a profit margin. Maybe you can explain it by their being in league with Satan and eating babies, or something.

    “pythagorean economics”
    -SD

  60. rfrancis1980 says:

    @ Chris

    I can’t speak for SD but I would likely support age restriction on supplements that the FDA has demonstrably shown harm people just like we have age restrictions on alcohol and tobacco. Stores could even place them in more restricted areas like they do with alcohol and tobacco.

    Children can’t render consent, that is a privilege of adulthood.

    Maybe my low cholesterol is genetics, it is a possibility, on the other hand my mother has very high cholesterol. Doesn’t prove anything but it does beg the question as to why my cholesterol is low in spite of what I eat.

    @ Todd W.

    You didn’t read my post very carefully did you. I don’t like government telling me what to do with my own body, I think the drug war is an affront to the idea of individual liberty. My position has nothing to do with making money.

    I think crack should be sold in package stores not because I want package store owners to make lots of money off of crackheads but because I think crackheads should be allowed to smoke crack.

    @ SD

    I haven’t read Rand myself, I just try to live by a simple principle:

    “your body, your property, your choice”

    When I run across legislation or opinions that run counter to that it tends to get me riled up.

    Serenity now, serenity now.

  61. Chris says:

    So, rfrancis1980, you agree that Boyd Haley’s OSR should be checked out by the FDA.

    Unfortunately, the free market does not always seem to filter out the scams before great harm is done. Regulations come around as reactions to the harms. The FDA started as a reaction to adulterated food and medications (which included putting antifreeze in pediatric medication). The regulations and one astute doctor are the reasons that the USA did not have as many disabled babies born due to thalidomide.

    And until SD comes up with a way to prevent deaths and disability due to unregulated supplements, I will ignore his pontifications.

    And yes, while my husband has low cholesterol, his mother who is not from Holland has borderline high cholesterol. As Dr. Ben Goldacre says: It’s complicated.

    I have read Ayn Rand. While I was first enthusiastic by the ideas in Atlas Shrugged I later matured and started to see that things were not what I thought they were when I was in my early twenties (partly by reading later Robert Heinlein stuff where he seemed to get very extreme). As noted before: It’s complicated.

  62. pmoran says:

    SD: “If you are not willing to argue that patients diagnosed with a serious disease are incompetent to determine the course and duration of their own treatment, and accept the consequences of that argument – bearing in mind that this a population under severe stress and ostensibly uniquely susceptible to woo – then by what argument do you claim that every member of the general population is incompetent to evaluate such claims accurately?”

    Your forte is entertainment, not arguing your case.

    We can assume that the former patient has been accurately diagnosed and properly advised about the consequences of their treatment choices. There are no such assurances in the DIY medicine encouraged by big Supp. Moreover some of our patients ARE deemed “incompetent” and end up as wards when their parents want to make poor treatment choices. Most approve of this, although we may not always agree with individual court decisions.

    Who claims that “every” member of the public is incompetent? It is, however, obvious that very few have the time, expertise or inclination to go through reams of primary evidence in order to evaluate the myriad claims made for supplements. For the vast majority supplement use involves choosing the opinion of one “authority” over another, on subjective appeal.

    Yes, that is also a person’s right when applied at their own expense and risk, as is making “just in case” choices where the data is unclear. But the state (meaning the rest of us) has a stake in not having too many people making themselves sick or knocking themselves off prematurely and it is in practice not nearly as glamorous a process as some like to think — often just some crook out to make a buck out of sick and gullible people..

    That, and I guess the intellectual absurdity of governments treating what are mostly plant poisons and a few mineral poisons as “dietary supplements”, is responsible for the objections to DSHEA, rather than the urge to control others that you assume.

    Over-the-counter remedies SHOULD be exceptionally safe, so that they can be used by anyone of any intelligence, in almost any dosage and for any purpose that they may be induced to choose them for.

    You also missed the best argument for having safe supplements available, which is that some may derive placebo benefits not easily found elsewhere, and that they may ease the burden of common everyday complaints upon medical systems.

  63. SD says:

    @pmoran:

    “But the state (meaning the rest of us) has a stake in not having too many people making themselves sick or knocking themselves off prematurely and it is in practice not nearly as glamorous a process as some like to think — often just some crook out to make a buck out of sick and gullible people..”

    Now there’s an interesting notion.

    Let’s think of some of the other things that “the state (meaning the rest of us)” has a stake in, shall we?

    (*) “The state” has an interest in preventing new HIV infections, since this infection is incurable, debilitating, and expensive. Because HIV-positive individuals can still transmit the virus even if they are being treated and are perfectly compliant with their treatment, and because there is no practical means of preventing them from having sex with other people who may or may not be infected, “the state” can be said to have an interest in feeding anyone who is HIV-positive into a cremation oven, since that is a 100% surefire way of preventing HIV transmission. (You can substitute “forced quarantine” if you like; we could perhaps establish an “HIV colony” on Molokai.) Since this would result in people not wanting to obtain testing for HIV (who wants to volunteer to be cremated?), “the state” (meaning “the rest of us!”) has an interest in mandatory yearly HIV testing.

    (*) “The state” has an interest in ensuring that people who are unqualified do not conceive and raise children, due to the “social cost” of ignorance. “The state” can therefore be said to have an interest in preventing conception by default, and permitting it only after a careful review process. It is therefore reasonable for “the state” to mandate the implantation of durable contraceptives in all women of childbearing age (IUD/Norplant/&c.), and to permit only those people who have gone through a careful vetting process for suitability to establish a family.

    (*) “The state” has an interest in ensuring that the average intelligence and health of the citizenry increases over time. Therefore, “the state” has an interest in preventing the transmission of heritable physical or mental defects. The most reasonable, effective, and cheap way to accomplish this goal is to permanently sterilize the carriers of heritable genetic defects, thereby preventing the propagation of those defects through the gene pool, and to mandate the termination of any pregnancy where these defects are discovered to have arisen by random mutation. Imagine a world without sickle-cell anemia! Imagine a world without Down’s syndrome or Tay-Sachs! That can happen in *one generation* if we simply have the political will to do it!

    These sound like good ideas to you, yes? They proceed immediately from your assertion that “the state (meaning the rest of us)” has “a stake” in ensuring that the costs of one’s personal decisions are not “too high”. Do you disagree with this assessment, that the goals achieved outweigh the costs *if individual rights are not to be valued*, or are to be subordinate to “social good”?

    “filioque, yes or no?”
    -SD

  64. pmoran says:

    No SD, I don’t accept your slippery slopes and non-sequitors. They seem to derive from your own need for the comfort of naive, simplistic, absolutes. Real life is complex, especially where medical and ethical questions are concerned.

  65. rosemary says:

    Rfrancis1980, “None of you, NONE OF YOU, addressed his points on the removal of individual liberty such supplement regulation would result in. You guys are oblivious or do not care.”

    Sorry, but I don’t have the time or patience to wade through SD’s nasty rants.

    If either he or you would be kind enough to quote and give the page and line #s to the section of the proposed bill that you believe will result in “the removal of individual liberty” while leaving out the excessive emotional displays, I’ll be happy to try to address the issue from my personal perspective, but quite frankly I don’t see anything in the document the way it is now written to warrant any such fear.

  66. BillyJoe says:

    rfrancis.

    “P.S. Yes I take supplements, it’s how I found this article and site, I take Super B Complex, vitamin C, grape seed extract, and Omega 3 fish oil on a regular basis in addition to a multivitamin…”

    Why have you specifically chosen Super B Complex, vitamin C, grape seed extract, and Omega 3 fish oil, as opposed to all the other dietary supplements clamoring for your attention?
    Have you actually “chosen” or have you been duped by clever advertising? Perhaps you didn’t see the ads for noni juice, colloidal silver, or selenium supplements. Should you add them to your list? Maybe you need to see the adverts first.
    And maybe you missed the good advice about a varied diet – hey, what could be more natural, and cheap.

    ” and no I do not want the damn govt interceding to stop me.”

    Ah, yes, you’re your own man. Government can’t tell you what to do! You just let the advertising con men have one over you as long as you don’t know it’s happening it doesn’t count hey.

    “your body, your property, your choice”

    The question is, who is the master and who is the slave? Hint: your ideology has you by the balls.

    ” It may be anecdotal but my cholesterol last time it was checked was 110 and I eat kielbasa dogs and cheeseburgers almost every night.”

    Yes, kielbasa dogs and cheeseburgers and a multitude of dietary supplements expressly selected for you by the manufacturers ad men! How wise are you then?

    (BTW, a friendly piece of advise: leave that Sadomasochistic Dog to his one man circle jerk, you really don’t want to feed on his ejaculatory gutter prose. )

  67. mikerattlesnake says:

    The thing is, if he wasn’t such a jackass he could contribute to the discussion. I, for one, don’t think that supplements should be taken off the market. I do think that they should be stopped from making any health claims (even the vague ones) that are unproven. I agree with the second libertarian, whose name I can’t be bothered to go find, about legalizing the things we choose to put in our bodies. I just don’t think crack should be marketed as an immune-booster or a cure for fibromyalgia.

  68. EricG says:

    rfrancis (as per BillyJoe’s points)

    others to add to your regimen:

    dont drink ice water, it solidifies your food and prevents digestion – it is “one of the WORST things you could do for yourself! I learned this a looooong time ago!” (pretty convincing, huh!?)

    the interaction between the meat and cheese on a burger is good for you

    eating a berry cobbler is “good” for you, if its organic

    if you do not have high enough levels of anti-oxidants, you will have poor health (health as measured by a device that measures…nothing but the supplements you put in your body)

    all actual garbage speak proposed to me by Nu-Skin quacks. pitched to them originally, of course, *not* by anyone remotely learned in biology or medicine, but a salesman.

    ooh! almost forgot! don’t forget to include some craniosacral therapy to align your spinal cord and promote the flow of CSF! (the website sounded VERY sincere).

  69. Joe says:

    @mikerattlesnake on 12 Feb 2010 at 8:39 am “I, for one, don’t think that supplements should be taken off the market. I do think that they should be stopped from making any health claims (even the vague ones) that are unproven.

    All their health claims are unproven (to any degree of certainty). However, without those claims why would anyone buy them? Moreover, keep in mind that health claims must include safety as well as efficacy.

    Ephedra was an effective weight-loss supplement; but the effective dose led to serious injuries and deaths. And that was known, informally, to pharmacologists before ephedra was marketed as a supplement. Big Suppla sold the stuff, anyway, because it was still profitable after paying for the damage it caused. See “Natural Causes” by Dan Hurley (Broadway Books, 2006).

    Your suggestion, therefore, would defacto take them off the market; which is my position.

  70. David Gorski says:

    I, for one, don’t think that supplements should be taken off the market.

    And no one here is saying that they should be banned, actually. Not even me. All the McCain bill would do is to require more disclosure of adverse events and give the FDA mandatory recall power. I have, however, seen some outrageous “OMG they’ll get my supplements if they pry them from my cold, dead hands” sort of posts criticizing the bill.

    I do think that they should be stopped from making any health claims (even the vague ones) that are unproven.

    Indeed. I wish the McCain bill went further. It would be really fantastic if the FDA could actually do something about deceptive “structure-function” claims that supplement manufacturers make; however, we have to take what we can get in the real world. It will be hard enough for McCain to get this bill passed.

  71. The supplement manufacturers don’t need to make any claims. If I write a book about how vitamin D cures cancer and you sell Vitamin D in generic, claim-free bottles, we both win. Especially if your website links to my website.

    And neither of us has violated a law.

  72. Jeff says:

    I’d like to know why Joe thinks supplements should be banned. Most of the Ephedra deaths would have been prevented by mandatory recall authority, allowing the FDA to remove it from the market quickly. Adverse event data collected by the FDA and the AAPCC show supplements to be safer than food. Supplements don’t kill people:
    http://www.orthomolecular.org/resources/omns/v06n04.shtml

    Dan Hurley’s book, Natural Causes, is simply not credible. Here’s my review, posted at Amazon:
    http://www.amazon.com/Natural-Causes-Politics-Americas-Supplement/product-reviews/0767920422/ref=cm_cr_dp_synop?ie=UTF8&showViewpoints=0&sortBy=bySubmissionDateDescending#R2VIAZTA1MXHJA

  73. mikerattlesnake says:

    Well Joe, it seems you’ve elaborated in a way that I didn’t think I would have to. I am not pro-supplement and I don’t buy the stuff at all. What I am is against making (for the vast majority of cases) harmless substances illegal. Burger King is worse for you than most supplements. I think defacto removal from the market through reasonable legislation is preferable to forceable removal from the market by questionable legislation.

    I am pro-honest advertising and I think this goes beyond supplements (but that’s neither here nor there). I definitely believe that if supplement makers couldn’t make any spurious health claims and were required to disclose all ingredients, their sales would go down and the only people buying it would be people who went out of their way to believe in BS. I think this would lead to a scenario like the one allison describes more than an actual removal of all supplements from the market, but at that point I don’t think it’s up to anyone (save for maybe a caring friend or family member) to step in and prevent that person from seeking his dubious treatment. I also think occasional supplement use is better than over-treatment by pharmaceuticals, so if someone needs a placebo fix they may as well take a few vitamins.

    I am also not opposed to banning supplement sale in pharmacies. My girlfriend works at a CVS and the things that are sold there are ridiculous. Magnetic footpads, homeopathic cures, etc. Pharmacies are doing a huge disservice by providing false legitimacy to these products. That said, if the suplement companies couldn’t make health claims and people became more aware of what they were buying, this might work itself out without legislation, which is preferable.

  74. rosemary says:

    Jeff, “Supplements don’t kill people:
    http://www.orthomolecular.org/resources/omns/v06n04.shtml

    The site states, “There was not even one death caused by a dietary supplement in 2008, according to the most recent information collected by the U.S. National Poison Data System.”

    That does not mean that supplements “don’t kill people”, that no deaths were caused by supplements in the US in 2008, that supplements did not kill and were not reported to have killed anyone anywhere in the world in 2008 or that they will not kill people in the future. How do you know there isn’t something out there like cigarettes for which the adverse effects, often lethal, don’t take decades to appear?

    Supplements have very definitely killed people. I have spoken with the loved ones of two of them. Those survivors believe that their family members never would have taken the supplements that killed them if they had known what they really were, what their pharmacological action really was.

    Supplements have also caused many very serious injuries. I speak with victims and have worked with their lawyers. (Incidentally, most of those I know who get settlements sign confidentiality agreements that prohibit them from talking about their cases.) In my experience victims very rarely come forward. They are too ashamed and blame themselves for being stupid enough to believe outrageous claims about the benefits and safety of supplements. With several I’ve been in contact with who, due to embarrassment waited years before trying to find a lawyer to represent them, it was too late. The statute of limitations had expired.

    I do not now and have never wanted supplements banned. Neither do I want alcohol or cigarettes banned, but if you are going to sell cigarettes and alcoholic beverages and insist that they are safe but can’t present any evidence demonstrating that, I want you prosecuted for fraud in advertising and I want the penalties for those convicted harsh enough to act as deterrents.

    I don’t care if supplements are sold in pharmacies as long as they are clearly distinguished from OTCs. They should be sold in a separate area where there are signs stating that no government or scientific agency has reviewed them to see if they offer benefits or are safe or to determine if the ingredients on the label are those in the package and each container should carry such a notice. But I assure you that the supplement industry doesn’t want this because a committee that included some of the biggest players in the industry ignored it when I proposed it.

    I am still waiting to see what specifically about the McCain bill commenters believe will result in the ban of supplements on the US market.

  75. BillyJoe says:

    “Pharmacies are doing a huge disservice by providing false legitimacy to these products. ”

    In Australia there has been a recent move by pharmacists to hire “nurse practitioners” to see patients with “minor problems” not serious enough to see a doctor. Those nurse practitioners are to have limited prescribing rights and their sercvices are to be available under Medicare.
    Any one see any conflict of interest here? Anyone see an explosion in the use of the useless remedies sold by pharmacists?

    “I am also not opposed to banning supplement sale in pharmacies.”

    Maybe not, but the sale of these and other products (eg homoeopathy) is to my mind professionally irresponsible, just as it is for a doctor to recommend or perscribe them.

  76. Joe says:

    @Jeff on 12 Feb 2010 at 3:29 pm “I’d like to know why Joe thinks supplements should be banned.”

    I am sorry I was not clear- supplements have not been proven safe and effective.

    @Jeff on 12 Feb 2010 at 3:29 pm “Ephedra deaths would have been prevented … Supplements don’t kill people …

    So, ephedra supplements caused “deaths” … but did not “kill” people? How do you figure that? And the people who took contaminated stefania and survived due to kidney transplant (followed by removal of the cancerous, original kidneys) don’t count for anything? Why?

    Then there is your defense (in your Amazon review) of tryptophan as a supplement, despite it causing 38 deaths to account for. Are a mere 38 deaths not enough for you to care about?

    I should also have mentioned the incompetent and fraudulent manufacture of supplements such that one never really knows what one is buying. That is, the amount of named material in a dose is unregulated, and there can be dangerous (sometimes, deliberate) contamination.

  77. Joe says:

    @mikerattlesnake on 12 Feb 2010 at 4:29 pm “… What I am is against making (for the vast majority of cases) harmless substances illegal.

    How do you know what is harmless, these products are not tested for safety? Many products that were available for centuries have been removed from the market due to long-term, serious toxicities. Sassafras is carcinogenic, by the time the disease manifests itself people do not consider the sassafras since they had been ingesting it for a long time.

  78. pmoran says:

    I am not sure how you would even go about making DSHEA-type supplements illegal, yet that seems to be the tacit objective of some skeptics.

    How is it proposed that this be achieved, and enforced? How will the banned products be chosen?

    Perhaps it is not meant literally. If so, we should make that clear. Some believe that we want to take their vitamins away.

    This is why we have medical adverse reactions and deaths thrown in our face all the time.

  79. David Gorski says:

    I am not sure how you would even go about making DSHEA-type supplements illegal, yet that seems to be the tacit objective of some skeptics.

    Really? Which ones? Who has said they want to outlaw DSHEA-type supplements? Please be specific and provide quotations.

  80. BillyJoe says:

    “Really? Which ones? Who has said they want to outlaw DSHEA-type supplements? Please be specific and provide quotations.”

    Well…you know…it’s like…THEY say that…you know…THOSE people…the ones that want to take our precious supplements away from us.

    :D

  81. Fifi says:

    The claims about banning supplements initially seem to come from two main sources – both that make money promoting and selling supplements. It started with them creating hysteria around changes to the Codex Alimentarius and was mainly driven by healthfreedomusa.com (run by General Stubblebine whose certainly no friend of reality-based thinking but is a friend of Scientology) and also naturalnews.com (run by vitamin pusher and apologist for Scientology, Mike Adams). Not surprisingly, they’re buddies.

  82. pmoran says:

    David: “Really? Which ones? Who has said they want to outlaw DSHEA-type supplements? Please be specific and provide quotations.”
    ===========
    Not you, of course, David. You have stated otherwise. But what would you deduce from this exchange? —–

    “@mikerattlesnake on 12 Feb 2010 at 4:29 pm “… What I am is against making (for the vast majority of cases) harmless substances illegal.”

    How do you know what is harmless, these products are not tested for safety? ”

    Or this ?

    “Your suggestion, therefore, would defacto take them off the market; which is my position.”

    Or this?

    “@Jeff on 12 Feb 2010 at 3:29 pm “I’d like to know why XXX thinks supplements should be banned.”

    I am sorry I was not clear- supplements have not been proven safe and effective. ”
    ===========

    I am sure I could find numerous other examples if I cared to look. The stance in question is not necessarily explicit, but it is also clearly not always challenged when put to us.

    Is there anywhere on this site, or even on Quackwatch, any position statement as to what kind of regulation we desire concerning non-FDA approved medical products? I don’t think so. The public is free to make certain deductions from whatever rhetoric they encounter.

  83. Joe says:

    Inre pmoran on 13 Feb 2010 at 8:01 pm, I am the guilty party. Perhaps the discussion has become too philosophical for my taste. The first of my comments did not support banning supplements, I simply observed that the safety of those products is unknown.

    The second quote from me that removing products with no proven nutritional or health benefit is my position. I stand by that, after all they don’t contribute anything to a person’s well-being. Selling them for some imaginary benefit is fraud, and that should be recognized by the law.

    The third statement follows from the second. Let manufacturers prove the safety and efficacy of their products and we can call them drugs.

    As a practical matter, they will never be banned, Big Suppla is too powerful and Congress is too gullible.

  84. squirrelelite says:

    Happy Valentine’s Day, everybody.

    For those interested in the history of attempts to ensure safe food and medicines in the U.S., the FDA’s history page is a useful quick read:

    http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm

    It is a bit dated. The original article was written in 1981 and, despite a minor change in 2009, the last significant event mentioned was the Infant Formula Act of 1980. It discusses the 5 year negotiating and lobbying process needed to get the FDC Act of 1938 passed, but doesn’t mention the blanket exemption given in that act to homeopathic “medicines”. And, it doesn’t mention the DSHEA of 1994.

    Nevertheless, I found a couple of quotes that are interesting and illustrate the battle we are still fighting.

    The orginal food and drug act was passed in 1906, but

    “False therapeutic claims for patent medicines had escaped control in 1912 when Congress enacted an amendment outlawing such claims but requiring the Government to prove them fraudulent; i.e., that the promoter intended to swindle his victims. A defendant had only to show that he personally believed in his fake remedy to escape prosecution — a major weakness in the law for 26 years.

    This was eventually addressed in the FDC act of 1938 and

    “The Drug Amendments of 1962, passed unanimously by the Congress, tightened control over prescription drugs, new drugs, and investigational drugs. It was recognized that no drug is truly safe unless it is also effective, and effectiveness was required to be established prior to marketing — a milestone advance in medical history. Drug firms were required to send adverse reaction reports to FDA, and drug advertising in medical journals was required to provide complete information to the doctor — the risks as well as the benefits.”

    Unfortunately, the state of regulation and protection in the supplement and alternative “medicine” business is still reminiscent of conditions before 1906 when

    “Medicines containing such drugs as opium, morphine, heroin, and cocaine were sold without restriction. Labeling gave no hint of their presence. Otherwise harmless preparations were labeled for the cure of every disease and symptom. Labels did not list ingredients and warnings against misuse were unheard of. What information the public received came frequently from bitter experience.”

  85. Fifi says:

    The vast majority of the “they’re going to ban vitamins and herbs” hysteria and astroturf activism can be traced back to some pretty dubious sources and started with the attacks on the changes being made to Codex Alimentarius. Key players are healthfreedomusa.com (General Stubblebine and Rima Laibow’s site that sells vitamins, they’ve both got some weird connections to Scientology and Laibow often uses Scientology terminology) and healthnews.com (Mike Adams is also an apologist for Scientology). The other source is the anti-medicine pro-supplement site “Dr Rath’s Health Foundation”, which claims that healthfreedomusa.com is a black ops disinfo campaign designed to destroy the “health freedom” movement. If it wasn’t so creepy it would all be pretty funny in a Dr Strangelove truth-is-stranger-than-fiction kind of way. Propaganda is always an attack on reality-based thinking and Stubblebine spent a lot of time investigating new age stuff and mind-control (as retarded/just plain nuts as all the healthfreedomusa.com stuff really is).

  86. pmoran says:

    It is intriguing that we skeptics would be the last persons in the world to accept that medical truth be left wholly in the hands of any authority, even one that claims to be guided only by the very best of evidence. We know better than we did a few decades ago how even “Gold Standard” evidence can be manipulated and misrepresented. Even WE can be manipulated by incomplete data.

    And safety in medicine is a relative term — a trade off against benefits. This raises another question: before what jury would we be able to effectively argue that folk medicines, if reasonably safe, have no redeeeming social or medical benefits whatsover? (Try that here if you wish).

    We might look less like control freak rednecks if our rhetoric better reflected the complexities of the medical world, rather than sputtering indignation at sections of medicine being taken over by frauds and nutcases,

    Our position should perhaps be “we agree that we should not have all medical eggs in the one basket, but can we do something about these specific problems? They are in your interest, too”

    1. David Gorski says:

      It is intriguing that we skeptics would be the last persons in the world to accept that medical truth be left wholly in the hands of any authority, even one that claims to be guided only by the very best of evidence.

      Oh, come now. That’s huge straw man argument. There is no one medical authority, and even if the DSSA of 2010 were to pass that wouldn’t change. What would hopefully change is that we’d have some actual reporting and data upon which to base future studies and future regulatory decisions. We’d also have a better mechanism to recall rapidly supplements shown to be dangerous, rather than having to wait ten years for, say, ephedra to be banned. Nothing would change with respect to supplement manufacturers not having to prove their claims pre-marketing.

  87. Joe says:

    @pmoran on 14 Feb 2010 at 3:30 pm “And safety in medicine is a relative term — a trade off against benefits.”

    It certainly is, and the first step is not using un-needed drugs. In this case, there is no reason to ingest bio-active substances whose activity is not directed towards healing the ailment at hand.

    @pmoran on 14 Feb 2010 at 3:30 pm “This raises another question: before what jury would we be able to effectively argue that folk medicines, if reasonably safe, …”

    So, I will ask you- how do you know which ones are safe? The list of herbs, in use for centuries, that are unsafe grows regularly. Plus, due to inadequate quality control, herbs are often contaminated with dangerous substances which range from environmental materials (heavy metals, insecticides), toxic look-alike herbs, and deliberately-added drugs.

    Here is a recent, short review:
    Roger W. Byard “A Review of the Potential Forensic Significance of Traditional Herbal Medicines” J Forensic Sci, January 2010, Vol. 55, No. 1 pp. 89-92.

  88. Jeff says:

    Joe: Let manufacturers prove the safety and efficacy of their products and we can call them drugs.

    Large, long-term, placebo-controlled studies are very expensive. Only drug companies, through patent protection, can afford this kind of research. They can recoup costs by patenting the drug and charging very high prices. Under current law supplements (naturally-occurring substances) cannot be patented. Scientific proof they can prevent or even treat disease will be longer in coming. But an increasing number of cell studies, animal studies, and small human studies are showing supplements have real health benefits.

    David Kroll, an SBM contributor, was part of a research team which recenty published an important finding: The common herb Milk Thistle can prevent liver inflammation in children with leukemia receiving chemotherapy (see the Dec. 14 2010 edition of the journal Cancer).

    We know supplements are safe. They are also unpatentable and relatively inexpensive; I hope they stay that way.

  89. pmoran says:

    Me: “It is intriguing that we skeptics would be the last persons in the world to accept that medical truth be left wholly in the hands of any authority, even one that claims to be guided only by the very best of evidence.”

    David: “Oh, come now. That’s huge straw man argument. There is no one medical authority, and even if the DSSA of 2010 were to pass that wouldn’t change.”
    =============================
    I had in mind the suggestion that supplements should be “shown to be safe and effective”.

    An authority would certainly be required to decide when the required standards have been met and what those standards should be. It would presumably also have to pronounce upon the most trivial of claims (this will soothe your cough) and have problems when the evidence is not clear.

    But the biggest problem may be that it demands an unlikely level of public trust from those who prefer to “make their own decisions” and those who are already for a variety of reasons viewing the medical system with suspicion.

  90. SD says:

    Govorit’ Cde. Gorski:

    “Oh, come now. That’s huge straw man argument. There is no one medical authority,”

    Not quite, but close. The AMA might tend to disagree with you.

    “…and even if the DSSA of 2010 were to pass that wouldn’t change. What would hopefully change is that we’d have some actual reporting and data upon which to base future studies and future regulatory decisions. We’d also have a better mechanism to recall rapidly supplements shown to be dangerous, rather than having to wait ten years for, say, ephedra to be banned.”

    Yeahhhhhh… About that ban, there.

    You know, it’s funny. I go to Google and type the following words:

    “buy ephedra online”

    I then look at the amazing number of Web sites willing to sell me ephedra. Looking closer, I find that some of these substances ostensibly contain bitter orange (containing synephrine, so the Old Grey Lady tells me, a close relative of ephedrine); some contain what is styled “ephedra extract”, ostensibly not regulated by the FDA (or so they say); some appear to be shipped from elsewhere in the world less prone to nannyism at this level of goofiness. Many sites are presumably fraudulent; the substance obtained in many cases is probably powdered dog turd or something similar. (Hey, it’s a weight-loss supplement – tapeworms help you lose weight, right?)

    See how that works, Comrade? “Regulation doesn’t do what you think it does.” (“That word… You keep using that word. I do not think it means what you think it means.”) What it appears to have accomplished is, in no particular order:

    (*) Forcing manufacturers of this substance to find lower-quality substitutes, driving up the price. (Ephedra *was* the best source of ephedrine for supplement use.)
    (*) Encouraging a fast hunt for loopholes in the law, which are now being exploited.
    (*) Enriching importers.
    (*) Creating a flourishing black market.

    So: How’s that ban working out, Comrade? I guarantee you that everybody who wants ephedra today can still get it, your glee over its regulatory extinction notwithstanding. (“Reports of ephedra’s death have been greatly exaggerated…”) All together now, “REGULATION AFFECTS SUPPLY, NOT DEMAND”. All you’ve accomplished is to make it more expensive, *more* dangerous than it already was (see previous observations on “the effects of black markets on quality and price”), and encouraged further (healthy) mistrust on the part of the general public for regulatory agencies (“they took my diet pills away; screw ‘em”). An intelligent Comrade – if we posit that there *must* be a regulatory solution to this alleged “problem” (how many deaths can be attributed to ephedra, again?) – might have been satisfied with a mandatory black-box warning, since his goal is not to outlaw supplements (right?), but only to “ensure their safety”. Since a black-box warning is okay for “real” drugs, should work here, right?

    “Nothing would change with respect to supplement manufacturers not having to prove their claims pre-marketing.”

    I think you glossed over an important observation in this thread – it isn’t necessarily the supplement companies who do the marketing. A variety of *writers* do the marketing; the supplements sell themselves, more or less. Dr. X says “You should take ginkgo biloba”, readers of Dr. X buy ginkgo. Dr. X does not necessarily work for a supplement company.

    “never go up against a sicilian…”
    -SD

  91. SD says:

    @pmoran:

    “An authority would certainly be required to decide when the required standards have been met and what those standards should be. It would presumably also have to pronounce upon the most trivial of claims (this will soothe your cough) and have problems when the evidence is not clear.”

    Clearly you have not been listening to the Comrade. There are no “secondary effects” to regulation. That is because all possible effects of regulation can be foreseen, and so nothing happens that was not expected and willed by the People. Regulation is by definition perfectly in harmony with the People’s Will, as interpreted by their organs. (And when it comes to organs, none is bigger than Cde. Gorski. *pada-rump-ump-ump* Thank you, thank you, I’ll be here all week…) The idea that commanding obedience by fiat does not necessarily work is a counter-revolutionary lie spread by the unscientific lackeys of the international bourgeoisie, erm, I meant woo.

    “But the biggest problem may be that it demands an unlikely level of public trust from those who prefer to “make their own decisions” and those who are already for a variety of reasons viewing the medical system with suspicion.”

    Nawwwwwww. People *love* to have things jammed in their ass. Especially when it’s “for their own good”. That line by itself makes everything all better. Eventually the recipients of this treatment come to like it, and demand more.

    “insert c.s. lewis quote here”
    -SD

  92. Joe says:

    @Jeff on 15 Feb 2010 at 12:14 am “Large, long-term, placebo-controlled studies are very expensive.” Yada, yada

    I have never understood how your customers benefit from unproven products sold as if they had merit.

    @Jeff on 15 Feb 2010 at 12:14 am “David Kroll, … published an important finding: … Milk Thistle can prevent liver inflammation in children with leukemia receiving chemotherapy (see the Dec. 14 [sic, Jan. 15] 2010 edition of the journal Cancer).”

    Yours is an over-interpretation of the research: “Despite our study’s limitations, it provides preliminary evidence that MT may be a safe, effective, supportive-care agent. Future investigations are needed …”

    @Jeff on 15 Feb 2010 at 12:14 am “We know supplements are safe.”

    No, we do not. You imagine they are safe.

  93. David Gorski says:

    I had in mind the suggestion that supplements should be “shown to be safe and effective”.

    But that isn’t even part of the DSSA of 2010. All the DSSA of 2010 does is to mandate more reporting of adverse events and to give the FDA mandatory recall power, both reasonable additions to the FDA’s armamentarium. If the bill had included something that could let the FDA go after bogus “structure-function” claims, it would have hit the trifecta of fixing the DSHEA. However, I suspect that latter regulation will never come to pass. Big Suppa is just too powerful.

  94. Fifi says:

    SD – “I think you glossed over an important observation in this thread – it isn’t necessarily the supplement companies who do the marketing. A variety of *writers* do the marketing; the supplements sell themselves, more or less.”

    Depends what you mean when you say “supplements” – do you mean your basic vitamins or “supplements” that are various combinations of herbs like Juice+ and so on? It’s usually supplement companies doing the marketing – releasing press releases about their product, buying advertising and premium placement on shelves, and offering specials offers on their products. Vitamin manufacturers (or bottlers) also market their brand. Anything branded is marketed – often very heavily and often trying to pass off marketing materials as being autonomous writers or publications merely presenting articles or health advocacy groups. Supplement manufacturers do some of the most deceptive marketing and astroturf campaigning out there (next to pharmaceutical companies…well, and oil companies). The biggest joke of all is that people who think Big Pharma is out to exploit them are so blindly trusting of Big sCAM.

  95. rosemary says:

    Jeff, “Large, long-term, placebo-controlled studies are very expensive. Only drug companies, through patent protection, can afford this kind of research.”

    While it is true that it costs a lot of money to do the studies required to have a drug approved by the FDA, no one pulls a substance from the shelf in a chemistry lab or picks a leaf in the jungle and rushes to the FDA to get it approved as a drug. When scientists suspect that something may have beneficial properties, they test it to see starting with small inexpensive tests. For instance, if they think it kills bacteria, they test it against bacteria in vitro, in test tubes, to see if they are correct. If they keep doing such tests and getting positive results, they publish their studies and move on to more advanced studies, such as those in animals, and if those results are positive, they publish them so others can try to replicate them. Only after many such small, inexpensive studies show that a substance is promising do they even think about “large, long-term, placebo-controlled studies.” It is the scientific way.

    Supplement salesmen on the other hand pull products out of a hat or hear stories about “cures” and then sell the products without any tests at all, not even the small, simple, inexpensive ones, which means that in reality they have no idea whether or not their products offer benefits and are safe. All they have is hope or crossed fingers. It’s the supplement way.

    If scientists suspect that something offers benefits, they test it to see no matter whether it can be patented or not because they are interested in finding cures. Look at all the studies on substances that can’t be patented like vitamins.

    While it may be true that a supplement manufacturing company cannot make money on a substance that can’t be patented, that doesn’t mean that no one can, such as the suppliers, growers or the processors who work for them. Just because potatoes, oranges, grapes, salt, milk and other food products can’t be patented hasn’t stopped farmers from growing them or companies from processing them into other things like potato chips, orange juice, wine. (Remember according to DSHEA supplements are foods after all and food is studied all the time.) Neither has the inability to patent them prevented producers and processors from making money or from doing research.

    Silver can’t be patented, but one silver mining company bought a controlling interest in a silver supplement company because the supplement increased the value of silver 50 fold, not 50%, 50 fold. It would be very easy and inexpensive for the silver producers, who have a trade organization, to sponsor studies to determine if silver supplements offer benefits and are safe, and if the studies showed that silver does even a fraction of what the salesmen claim, lots more people would buy silver supplements providing a very nice profit to the silver miners over and above the cost of the studies. But they aren’t doing any such studies. My theory is that that is because they know that such studies would put a big dent in the bottom lines of the silver supplement companies by demonstrating that silver doesn’t offer any benefits whatsoever although it can permanently disfigure you. Actually, I believe the reason that none of the supplement companies do research is not because the ingredients can’t be patented but because they know how bad the results would be for their bottom lines. They’d put them out of business very quickly.

  96. rosemary says:

    I’m still not wading through SDs nasty rants although I’ve noticed that he is still posting them. Unless I’ve missed it, which is quite possible since I’m not reading them, I have to assume he hasn’t provided quotations from the McCain bill indicating what he believes will result in the ban of supplements in the US which forces me to conclude that he can’t find any such language in the bill. I certainly can’t.

  97. pmoran says:

    Me: “I had in mind the suggestion that supplements should be “shown to be safe and effective”.”

    David: “But that isn’t even part of the DSSA of 2010.”

    ==========================================

    I didn’t say it was. Bluntly, my point was that skeptics unwittingly help create the climate of paranoia that exists within alternative medicine regarding ANY regulation.

    “Alternative” supporters know that any system based upon the objectives stated above would consign almost the whole field of AM to an “illegal” scrap heap and the rest to bitter argument.

    They know this, because every alternative claim IS seemingly automatically challenged by the mainstream. So while they themselves may value mainstream input as a kind of initial coarse filter for medical claims, they will violently oppose having their personal treatment options limited entirely to what its working better than placebo clinical trials allow.

    For the lay person’s instinct is to try “anything that might help” when faced with unresolved afflictions.

    Medical science operates through a foreign, even antithetical concept — the null hypothesis. The default assumption is that any medical claim is false — unless otherwise shown to a very high standard of evidence.

    Do you see the problem? The null hypothesis may be a needed device when scientific rigor is at stake, but it is a hopelessly unrealistic and even oppressive basis for regulations affecting public medical behavior or commerce.

  98. Fifi says:

    pmoran – “They know this, because every alternative claim IS seemingly automatically challenged by the mainstream.”

    While I agree with your overall point, I think it’s more than that. Most of the challenges aren’t really coming from the mainstream per se, or at least what most people outside of science and medicine see as the mainstream. People tend to see research and science as esoteric, mainstream vis a vis medicine generally means their family doctor and what they see in the media. In that sense, quite a bit of CAM is now pretty mainstream, certainly vitamins and minerals are and family doctors do recommend taking a multivitamin as a precautionary measure quite often. A lot of GPs also don’t lecture their patients about CAM, if it seems harmless and it makes the patient feel better, is it really a big deal? Informing about the dangers of extremism, sure. But getting bent out shape because someone takes a CAM cold remedy as opposed to the equally useless (and sometimes harmfull) “medical/pharmaceutical” over the counter cold remedies is a bit silly!

    And a family don’t shouldn’t get bent out of shape if they’re asked about vitamins and minerals. It’s not vitamins and minerals that are woo, it’s unproven regimes, mega-dosing and outrageous claims that are. Even then, the science around this changes constantly due to ongoing research into nutrition and health. In Canada, for instance, there’s been a fair amount of press regarding the research into vitamin D (as their should be, people need to be aware of what the research is starting to show since it’s highly relevant to Canadians and basic health). Of course, medicine has known about vitamin D for ages, which is why it’s added to milk but research is showing that it’s advisable for most Canadians to be supplementing with higher doses that previously thought.

    The other problem is when part of the medical establishment (or individual doctors) ridicule ideas or techniques that science ends up proving to have value or a basis in reality. A prime example of this is meditation. Often the ridicule extends to the people who try out things – sometimes out of curiosity, sometimes as a last resort – so it’s clearly personal for both the person doing the ridiculing and the person ridiculed. Also, trivializing the placebo effect or simply feeling better as some kind of personal weakness is just silly. People don’t just go to see their doctor to get well, they go to feel better. The two are pretty much the same for many people and certainly for a lot of self limiting conditions feeling better is about as good as it’s going to get.

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