“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are. After all, Who could argue with “health freedom”? How dare the government tell me what I can and can’t use to treat my own body? Of couse, as I (and others) have said many times before, in reality “health freedom” is a sham. In reality, “health freedom” is not an argument made for the benefit of the consumer; it’s an argument made for the benefit of the sellers of supplements. In practice “health freedom” really means freedom for quacks from any pesky laws and regulations that would prevent them from exercising their quackery.
So it was a couple of weeks ago when I saw two websites known for anything but science-based medicine (SBM), namely the quackery-promoting website NaturalNews.com and the quackery apologist blog Vitamin Lawyer Health Freedom Blog promoting a bill that I hadn’t heard of before, namely H.R. 1364, entitled the “Free Speech About Science” (FSAS) Act of 2011. This bill is being touted in all the usual “health freedom” venues as an antidote to what supplement manufacturers apparently see as the “overreach” of the FDA. For example, Ethan A. Huff of NaturalNews.com (where’s Mike Adams, one wonders?) urges his readers to tell Congress to support the Free Speech about Science Act of 2011., while “vitamin lawyer” Ralph Fucetola subtitles his post HR 1364, S.216 and the Struggle for Health and Food Freedom Action Item. So, while we’re waiting to find out how badly Steve Novella’s appearance on The Dr. Oz show today ends up being edited, let’s take a look at what these advocates for dubious supplements say?
First, Ethan Huff:
As many NaturalNews readers probably already know, the US Food and Drug Administration (FDA) has severely limited the free speech of practically everyone besides drug companies. Supplement manufacturers, natural food companies, and even produce growers are prohibited from making honest, scientifically-proven health claims about their products, even when such claims are supported by peer-reviewed studies. As a result, millions of Americans are left in the dark about how natural foods, herbs, and supplements can help them prevent and cure disease.
This is where FSAS comes in. If passed, the bill will amend current law to allow growers and manufacturers to freely share honest information about food and supplements with their customers. While the bill will still allow the FDA and the US Federal Trade Commission (FTC) to go after companies that are truly making false claims, the agencies will no longer be able to tyrannize those companies that simply share the truth with the public.
Now, Ralph Fucetola:
Our gripe is aimed not at all those good folk who turn to Congress for protection, but at the Congress-critters who vote to protect us (or not) only to do nothing when the FDA thumbs its collective nose at Congress and the People by ignoring the protective laws Congress has adopted.
Frankly, we thought we had won the battle over being allowed to communicate truthfully about health and food in Congress and in the Supreme Court.
We thought that’s what DSHEA was supposed to have done in 1994 with its Third Party Literature Provisions.
“Communicate truthfully.” You keep using that phrase, Mr. Fucetola. I do not think it means what you think it means. The same for a lot of phrases Mr. Fucetola and his buddies use. “Health freedom,” for instance. Of course, I suppose Mr. Fucetola could argue that he’s not being as disingenuous as I perceive him to be in that most of the supplement hawkers making health claims for their foods or supplements probably do believe them to be true and therefore are not, strictly speaking, lying. That doesn’t mean that such claims shouldn’t be regulated.
At least Mr. Fucetola is honest enough to point out that the purpose of the DSHEA of 1994 was to permit more–shall we say?–liberal “free speech” by supplement manufacturers and sellers. That “free speech” in practice frequently means “making stuff up.” Of course, many of us here at SBM have been quite critical of the DSHEA of 1994. Although well-intentioned to some extent in trying to clarify different standards for regulation for foods compared to medications, in essence the DSHEA has turned out to be a huge boondoggle that allows supplement manufacturers to label their supplements as “foods” when they are in reality being sold for medical purposes and even when it takes an even more “liberal” interpretation of the definition of “food” or “nutrient” to make them cover many of the supplements being sold in the U.S. Peter Lipson quite rightly referred to this law as a “travesty of a mockery of a sham,” basically pointing out that sellers of supplements, for example, have a “get out of jail free” card and can make almost whatever claims they want for supplements as long as they include a Quack Miranda warning and keep their claims vague enough, as in, for example, the ever-infamous “boosts the immune system” or “promote detoxification.” Reports from the Government Accounting Office and the Institute of Medicine recommending tighter regulation of dietary supplements have in general come to naught.
The reason such calls have come to naught is because supplement manufacturers have become an increasingly powerful lobbying force and as a result have successfully managed to beat back any serious modifications to the DSHEA. Some of this is due to the increasing popularity of supplements. (A recent survey found that 50% of adults take some form of supplement.) Some of it is also due to the increasing number of pharmaceutical companies manufacturing supplements, a product that allows them to make what they want with very little of that pesky interference from the FDA. Supplements are highly profitable, too, and it doesn’t cost $1 billion to bring a new supplement to market, as it does for many new drugs. As a result certain powerful legislators are in the pockets of the supplement industry. For example, about a year ago, Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), the former of whom has received large contributions from supplement manufacturers in his state and the latter of whom is a true believer most responsible for the creation of the National Center for Complementary and Alternative Medicine (NCCAM) beat back an attempt by Senators John McCain (R-AZ) and Byron Dorgan (D-ND) to pass the Dietary Supplement and Safety Act of 2010. This law would have eliminated some of the loopholes in the DSHEA of 1994. At the time John McCain was facing a serious primary challenge to his reelection effort from the Tea Party right and caved because he decided that he couldn’t be perceived as being in favor of more government regulation.
Not surprisingly, the FSAS Act of 2011 (H.R. 1364) was introduced by Representatives Jason Chaffetz (R-UT) and Jared Polis (D-CO). Utah is, as we have seen, Orrin Hatch’s home state and a major center for supplement manufacturing in the U.S. Chaffetz, too, is in the pocket of the Utah supplement industry. Indeed, he is not only a former industry executive but also co-chairman of the Congressional Dietary Supplement Caucus, and his district is one of the biggest producers of dietary supplements in the country, boasting itself as the home of companies such as Nu Skin, Usana, MonaVie, Xango, and Tahitian Noni. As a result, his longstanding activism in promoting supplements and his potential challenge to Orrin Hatch for his Senate seat next year have led to speculation that the supplement industry might be forced to take sides. Meanwhile, other members of the Dietary Supplement Caucus include Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), as well as Representatives Dan Burton (R-IN), Frank Pallone (D-NJ), and–surprise! surprise!–Jared Polis (D-CO). Truly, big pharma may be a potent force in Congress, but “big suppa” is nothing to sneeze at, and it has major bipartisan support. Of course, this is something that advocates such as Huff and Fucetola won’t tell you.
So what does the law propose to do, really? Before I get to that, let’s go back in time a bit for some history.
A BIT OF BACKGROUND
The United States counts among its founding principles freedom and the idea that we don’t like the government telling us what to do. We’ve seen these ideas in conflict with other principles that there is a role for the government in protecting its citizens against fraud and harm that can result from adulterated food or medicines that don’t do what their manufacturers claim they can do. When the U.S. was a mostly agrarian nation with few large cities, the problems that resulted from patent medicines and adulterated food were not as major a problem as they became as more and more Americans poured into metropolises like New York and Chicago. In fact, federal protections against these sorts of fraudulent activities are a relatively recent development in the history of the U.S. Before the 1900s, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals; instead there was a patchwork of state and local laws designed to outlaw unethical practices, such as misrepresenting the ingredients of pharmaceuticals or making claims for them that can’t be backed up.
In the wake of muckraking like Upton Sinclair’s The Jungle, which dramatized the horrific conditions in meatpacking plants and the lack of attention to sanitation, which was part of a confluence of events that pushed Congress to pass the Pure Food and Drug Act of 1906, also known as the Wiley Act after its chief advocate, which resulted in the creation of the Bureau of Chemistry, which later became the Food and Drug Administration. This first incarnation of the FDA was relatively limited in power and mainly concerned with ensuring that food and drugs that were transported across state lines were properly labeled as to content. By the 1930s, however, the weakness of the Food and Drug Act was becoming apparent in the wake of reports of dangerous products that were permissible at the time, including radioactive beverages and worthless “cures” for diabetes and tuberculosis. In 1937, over 100 people died after using a drug formulated with a toxic solvent (diethylene glycol). There was little the feds could do after that; the only way they managed to prosecute the company responsible (Massengill Company) was for mislabeling the product as an “elixir,” which violated the 1906 Pure Food and Drugs Act, which stated that a company could not call a product an “elixir’ if it had no alcohol in it. Massengill paid a minimal fine, and the resulting public outcry resulted in the passage of the Food, Drug, and Cosmetic Act of 1938, which replaced the 1906 statute and greatly tightened up regulations governing the production of food, drugs, and cosmetics in the U.S.
Ever since, those selling dubious non-science-based remedies and advocates promoting “alternative” medicine, “complementary and alternative medicine” (CAM), and, more recently “integrative medicine” (IM) have been in conflict with laws that, whatever their shortcomings, demand testing for safety and efficacy. Of course, this conflict was to some extent embedded within the law itself, which regulates and protects homeopathic preparations, using the Homeopathic Pharmacopoeia of the United States as an official drug compendium.
Be that as it may, in the early 1990s, Congress was considering bills that would have increased the regulatory powers of the FDA and FTC over supplements in the wake of high profile cases of harm caused by unregulated dietary supplements. As a result, the health food industry and supplement manufacturers rallied its troops to stop such legislation with claims that Congress would take away citizens’ rights to buy vitamins and that many businesses would go under as a result fo this legislation. The end result was that Congress acted, but not to tighten up regulation. Rather, it defined “dietary supplements” as a separate regulatory category and made that regulation quite lax. Stephen Barrett of Quackwatch characterized its effect and intent thusly:
The Food, Drug, and Cosmetic Act defines “drug” as any article (except devices) “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or function of the body.” These words permit the FDA to stop the marketing of products with unsubstantiated “drug” claims on their labels.
To evade the law’s intent, the supplement industry is organized to ensure that the public learns of “medicinal” uses that are not stated on product labels. This is done mainly by promoting the ingredients of the products through books, magazines, newsletters, booklets, lectures, radio and television broadcasts, oral claims made by retailers, and the Internet.
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.
Given that the FDA is already chronically underfunded for the tasks it’s expected to carry out, for the most part, the FDA does little to regulate supplements because it has its hands full regulating pharmaceutical drugs. Perhaps the most insidious part of the DSHEA is that, while it allows so-called structure-function support claims (i.e., “boosts the immune system”) or claims based on nutritional support, it does not permit “drug claims.” The problem is, what constitutes a “drug claim” compared to a “structure-function” claim remains fairly vague, even after the FDA issued rules in 2000 that banned explicit claims that a product treats or prevents disease, there’s still considerable wiggle room, and enforcement isn’t exactly what we would call robust. In the meantime, supplement hawkers have cleverly used the Internet to circulate claims for these products that aren’t necessarily on the packages or in the package inserts.
H.R. 1364: The Free Speech about Science Act of 2011
In discussing H.R. 1364, it’s hard not to note how Orwellian the title of the act is. It’s very much of a piece with the term “health freedom.” After all, what red-blooded American could be against “free speech”? What are you, against the First Amendment or something? Are you un-American? That’s pretty much the tenor of the arguments being used to support this bill, whose full text can be found at The Library of Congress Thomas. In fact that sort of argument is right there, in the text of the bill:
The Congress finds the following:
(1) Federal regulators have forbidden–
(A) cherry growers and food producers to cite independent and respected scientific research on their produce that references health benefits; and
(B) a variety of dietary supplement makers to cite independent scientific research on health benefits from supplements from respected, peer-reviewed scientific journals.(2) Americans want access and have a right to access legitimate scientific information about foods and dietary supplements to ensure informed decisions about diet and health care. While the American public is inundated daily with advertisements about prescription drugs for health conditions, many of which could be prevented through lifestyle changes, proper nutrition, and informed use of dietary supplements, Americans are denied access to the very information that assists in making informed lifestyle and health care decisions.
(3) Providing access to scientific information promotes self-responsibility, thereby empowering Americans to exercise independent judgment in caring for themselves and ultimately reducing health care costs and improving quality of life.
(4) The United States has a long commitment to the free dissemination of scientific research with the exception of limited extreme situations for national security. This commitment goes back to the First Amendment to the Constitution and has contributed vitally to the Nation’s economic progress.
Proponents like Huff cite cases that, on the surface at least, sound reasonable. For example, Huff makes a lot of hay over the case of Diamond Nuts, which made claims that its walnuts could lower cholesterol, protect against heart disease, lower the risk of stroke, inhibit tumor growth, and a number of other disease claims. Huff argues that these claims are “based entirely on results from legitimate scientific studies.” Of course I could argue that claims for the efficacy of homeopathy, reiki, and “energy healing” quackery could similarly be “based entirely on the results of scientific studies,” as well. That doesn’t make them any less quackery. In the case of walnuts, as you might expect, things are a bit more complicated. Basically, Diamond Nuts made its claim based on studies suggesting that omega-3 fatty acids have been suggested to do these things, and its walnuts contain omega-3 fatty acids. The FDA replied:
There is not sufficient evidence to identify a biologically active substance in walnuts that reduces the risk of CHD. Therefore, the above statement is an unauthorized health claim.
As foodsafeguru put it:
Nuts are good for you and cut out the unnecessary claims that could lead consumers to think that if they ate enough walnuts, their CHD would go away.
US Food Safety understands that nuts have had a bad wrap since last year, but say what walnuts really do for you instead of guilding the lilly and deceiving consumers.
Another case that Huff cites dates back to 2005, when the FDA sent certified letters of warning to 29 cherry manufacturers (most of them right here in Michigan!) for making undue health claims for their cherries, complaining that “such claims included the truthful statement that cherries help reduce inflammation, which they absolutely do.” Unfortunately, it was much more than that, as this typical FDA warning letter to one of the cherry growers demonstrates. In it are documented claims by Amon Orchards that cherries prevent cancer. Not only that, but, according to Amon Orchards, they also contain a “natural chemical that not only flushes cancer-causing substances out of the body, but also helps stunt the growth of cancerous cells” and “anti-inflammatory pain relievers 10 times stronger than aspirin or ibuprofen,” that can “relieve aches and pains.” Even a cherry grower in Michigan basically admits that cherry growers were making health claims about its cherries when he writes on his website:
The FDA does not want the cherry industry to tell people that recent studies show that tart cherries contain substances that are potentially 10 times stronger than aspirin or ibuprofen for relieving pain. It does not want the public to know that substances in tart cherries may kill cancer cells and prevent cancer. It makes no difference whether these statements are true. What’s important is that the public not be told that a natural substance (tart cherries) has been shown to work as well as or better than an unnatural one (ibuprofen). Only drugs, according to the FDA’s legal doctrine, can prevent, treat, mitigate, or cure disease.
This same cherry grower then goes on to list even more claimed health benefits of cherries. The problem, of course, is the same problem as with the walnuts in that most of these studies are either preclinical studies, studies using compounds isolated from natural sources, or otherwise studies whose direct applicability to health claims for the food in question are tenuous at best. None of this has stopped the health freedom movement from making histrionic claims about an overbearing FDA, perhaps the most ridiculous example of which is Bill Sardi’s assertion that the FDA had “blood on its hands” for going after the cherry growers. Also, it’s not just the little guys who get into trouble with these claims. Food giant General Mills recently got into the same sort of trouble with the FDA due to its claims that Cheerios can lower cholesterol.
I once coined a term for what the anti-vaccine movement wants parents to hear when it calls for “informing” parents: “misinformed consent.” I called it misinformed consent because the anti-vaccine movement, under the guise of informed consent, exaggerates the risks of vaccines while downplaying the benefits, all with the intent to persuade parents not to vaccinate while disingenuously claiming that that is not what they are about. What supporters of the FSAS Act of 2011 are doing is very similar in my opinion; they are trying to take away barriers to misinforming potential customers, exaggerating the potential benefits of their supplements while downplaying potential risks, all in the name of making a sale. Unlike the anti-vaccine movement, however, it’s not just ideology (in the case of anti-vaccine activists, an unshakable belief that vaccines cause autism and all sorts of other problems), but profit as well that appears to drive them. To that end, from my perspective I see them seeking the freedom to distort the medical literature to exaggerate the health benefits of their products and even make claims that they can prevent or treat disease, as the cherry growers and Diamond Nuts appear to have done.
So what would H.R. 1364 mean if it were actually passed? I must admit that I’m somewhat torn on this. On the one hand, to some extent the FDA letters do on the surface seem a bit ridiculous, at least in the case of walnuts and cherries. They even appear a bit paternalistic. On the other hand, notice how all the arguments for H.R. 1364 made by its proponents are based on examples like cherries and walnuts, rather than actual manufactured supplements. There’s a reason for that. The purpose behind this law really does appear to have very little to do with freedom of speech. Rather, its purpose appears to be to neuter the FDA with respect to claims by food and supplement manufacturers to treat diseases. Remember, under the DSHEA, supplements are considered more akin to food than medicine. In other words, for purposes of the FSAS Act, cherries, walnuts, and Cheerios function as a Trojan horse that, once brought into the protected walls of the FDA through H.R. 1364 (if made law), would soon disgorge its contents of all manner of supplement manufacturers making direct health claims to treat and cure disease based on the flimsiest of “legitimate medical evidence.” Don’t believe me? Check out this “white paper” on the FSAS Act from the Alliance for Natural Health:
A few critics will accept that there is a revolution taking place linking nutrition directly to health. But they think that we should just focus on food, not on food extracts and supplements. There are at least two problems with this. First, studies show that the nutritional content of food has been declining for as long as the last 50 years (see especially the work of Dr David Thomas). The USDA has recently confirmed this analysis for more recent years. The problem seems to lie in depleted soil.
Second, nutrients sometimes have to be concentrated to have full therapeutic benefit. No one can get enough Vit D from food. We also get it from exposure to sunlight on our skin, but use of sun lotion prevents it. Food supplements often make sense either for routine day to day use in lower potencies or as higher potency therapies devised and supervised by doctors.
See the Trojan horse? The FSAS Act would remove the barriers to health claims made for foods like cherries or walnuts but in doing so it would also at the same time remove the barriers for the same sorts of claims for supplements that are concentrated extracts of food ingredients. Even the existing weak protections of the DSHEA would be gutted. No wonder practically every woo-supporting blogger is supporting the bill. No wonder the Association of American Physicians and Surgeons is supporting H.R. 1364 on its Take Back Medicine blog, all in concert with the Alliance for Natural Health and General Bert Stubblebines’ Natural Solutions Foundation, the latter of which is pushing an “action item” for the bill. If that doesn’t make the picture clear enough for you, look at SECTION 4(c)(2), where the “burden of proof” regarding charges of false advertising is shifted from the seller making the claim to the FDA:
In any proceeding under section 13, the burden of proof shall be on the Commission to establish that the literature being disseminated is not legitimate scientific research.
In other words, supplement manufacturers could claim anything they want, as long as they cite a scientific paper or two, and it would be up to the FDA to prove that those scientific papers aren’t “legitimate research.” What about cases where supplement manufacturers misrepresent legitimate scientific research, as the cherry growers did when they represented in vitro experiments as being evidence that cherries provide the health effects claimed in humans?
The problem, of course, is the current law and how supplements are defined. Right now, “nutritional supplements” can include substances that are not by any stretch of the imagination scientifically supported nutrients, vitamins, or minerals that are needed as part of food. As I cited above, a logical definition of “dietary supplement” would be something that really is a dietary supplement, a nutrient. That’s not how the DSHEA defines “dietary supplement,” and as a result the FDA is forced to treat foods like walnuts and cherries exactly the same as it treats melatonin capsules, vitamin D supplements, and even a “supplement” that is in reality not necessary in the diet at all and in fact started its life as industrial chelators before being touted as a treatment for autism. True, ultimately the FDA did shoot Haley down, but the very fact that he got away for so long with promoting his chemical as a “supplement” to treat autism for long points to the problem with current law. Moreover, under the current law, the FDA has no choice but to treat health claims for Boyd Haley’s OSR#1 (the aforementioned industrial chelator) the same way it treats health claims for walnuts and cherries and other products that are undeniably food. In fact, if the DSHEA were amended to eliminate that problem and to make a distinction between actual food and the various supplements manufacturers make that have only a tenuous connection with nutrition and food, I might even be able to support something like the FSAS act–but only if it were renamed the Free Speech About Food Act and meant it.
It won’t be, though. Supplement manufacturers benefit too much from the current law, which equates supplements, no matter how removed from having any role in the diet they might be, and food. Even though the FSAS Act of 2011 would be the worst of both worlds (supplements equalling “food” plus the ability of supplement hawkers to say anything they want to as long as they can point to a scientific study or two–which, by the way, they could fund–the same way that pharmaceutical companies do), Orrin Hatch, Jason Chaffetz, Jared Polis, Dan Burton, Tom Harkin, and the many other political allies of the supplement industry, aided and abetted by the AAPS, the ANH, and many other “health freedom” organizations, will do their best to see to that.
112 replies on “The wonderfully Orwellian Free Speech About Science Act of 2011 (H.R. 1364)”
Now the funny thing when it comes to regulation is that when the EU wanted to ask supplement manufacturers and homeopathic sugar pill makers to buy a registration and submit to a safety inspection to keep doing what they’re doing, no actual testing of product efficacy or anything like that mind you, just checking if the floors are dirty and people are wearing gloves and safety glasses, the European alt med industry was at arms.
But don’t get the wrong idea, they’re not at all about profits. They just want to help people unlike those insidious, money-grubbing villains in Big Pharma. And by help they mean telling people that buying whatever they’re selling will cure Stage X cancer (doesn’t matter which one, all cancers are the same to an alt med practitioner) even if there’s not a shred of evidence from a clinical trial showing that their claim is even remotely true, with zero oversight or accountability for their actions…
Another proof that the United States Congress is the best lawmaking body that money can buy
“Oh, what a tangled web we weave,” etc.
Fucetola has been a frequent guest on Radio Woo woo and is a trustee of the Natural Solutions Foundation ( with Stubblebine and Laibow), a major player in this fight.
Another frequent guest is attorney Robert Krakow, who is called the “vaccine lawyer”, a cohort of RFK, jr**, and has worked with LKH & co.
Why do the same names keep popping up as often as tired, old natural remedies are cited as “cures” by woo-meisters? Because there *aren’t* too many advocates involved in this. It’s a vanishingly small group of entrepreneurs ( and their entourage) who would benefit from changes in the law.
BTW, Jake Crosby goes all Dan Brown on us today @ AoA. I hate Dan Brown.
** RFK, jr has been associated with clean-up of the Hudson River and will host this year’s Shad Fest. Guess who else is also invited?
Because when I think of the FDA’s shortcomings, I think it’s because it has too much power and is too aggressive in regulating… oh wait
The cherry growers didn’t initially make any claims, the US Department of Agriculture did, saying tart cherry reduced inflammation as well as the deadly COX-2 inhibitors, and the FDA then followed by sanctioning the cherry growers for posting the USDA study, rather than the drug companies for their crime of hiding adverse (mortal) side effects. The cherry growers products killed no one, the COX-2 inhibiting drugs resulted in thousands of premature deaths.
In effect, what you have now in the marketplace is ineffective enforcement of existing regulations and online marketers of dietary supplements are making bogus claims all over the internet. The FDA and FTC are dragging their feet for unexplained reasons. The model for success in dietary supplement marketing today is to ignore existing regulations (Title 21, FDA labeling regs, FTC advertising guidelines) and wait till you get caught. This is despite laws being in place. Google, which should enforce advertising guidelines, just as the New York Times and NBC do, is remiss in allowing these bogus product claims online.
Judges have in the past ruled that information about dietary supplements cannot be censored and that the public is smart enough to judge for themselves, given that the studies cited are clearly marked as being lab dish, animal or human studies. When studies involve mortality, it may not be ethically possible to conduct human trials, so this must be considered.
The science is clear, that the biological action of many prescription drugs can be duplicated with dietary supplements at lost cost and with fewer side effects.
As for HR 1364, it is a can or worms.
Bill Sardi, Knowledge of Health, Inc. (who uses his real name, not a pseudonym)
Oh no, the evil greedy companies! They’re opressing… evil greedy companies. Hey, wait a minute. Back up the truck, Mack.
We’re not allowed to make scientifically proven claims for our products, even when there’s scientific evidence for real! Hey, hold on a minute… that should’ve been redundant. What’s going on here?
Oh right. Cherry growers want to cherry-pick single studies so they can make untrue medical claims. Big surprise.
Nice piece of work you spouted here, buddy. Couldn’t you come up with a few more ways to say “quackery?”
You didn’t mention the recent Supreme Court decision that destroyed the FDA’s claim that they could “regulate” supplement makers who made SCIENCE BASED CLAIMS on their products. The ruling works both ways, as it also allows peddlers of questionable mainstream medicines to do the same.
Oh, but way, I forgot about “cherry picking” results so that manufacturers can lay claim to all kinds of claims. Well, mainstream medicine does the same damn thing. How effective is that Hepatitis B shot you give newborns literally right out of the womb? You know, the shot that’s supposed to keep them from getting a SEXUALLY TRANSMITTED DISEASE? No proof it does anything worthwhile, but it’s recommended anyway.
And don’t forget the FDA’s own scientists who launched a backlash against the administration of the FDA (which still runs the show in that revolving door to Big Pharma that is the FDA) for ignoring science and approving medical apparatus regardless of safety and efficacy issues.
“Scienceblogs” my ass. This post is more like “science bile” spewed at something you have no idea how to understand. You know, science.
But I want to be able to bring back these products from the 1800s when they actually had cures for paralysis.
Just think of the millions of stroke survivors just waiting to be plucked.
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Sounds like it could help my apoplexy
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Dr Williams’ Pink Pills for Pale People
http://thequackdoctor.com/index.php/dr-williams-pink-pills-for-pale-people/
The same medicine cures
rheumatism, sciatica, neuralgia, paralysis, locomotor
ataxy, nervous headache, scrofula, chronic erysipelas,
and influenza
Allcock’s Porous Plasters
http://thequackdoctor.com/index.php/allcocks-porous-plasters/
The plasters were not only supposed to to help lumbago â other adverts suggested using them for such varied disorders as quinsy (you had to put a strip of plaster under your chin, stretching from ear to ear), diabetes, St Vitusâs Dance, epilepsy, dyspepsia, diarrhoea, coughs and colds, asthma, pleurisy, whooping cough, consumption, ruptures, sciatica, paralysis, rheumatism, tic douloureux and kidney problems.
GAMJEEâs ORIENTAL SALVE
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CURES Burns, Sores, Piles, Rheumatism, Paralysis, Lumbago, Stiff Joints, White Swellings, Wens, Hip Disease, Chest and Lung Complaints, &c., &c.
Allan’s Anti-Fat
http://thequackdoctor.com/index.php/allans-anti-fat/
Some adverts claimed it also cured dyspepsia, palpitations, rheumatism and gout, and prevented heart disease, apoplexy and paralysis.
Gag! Author probably is a sickly gent that takes yearly flu vaccines and pops rat poison pills to keep him from having a coronary while he spews blivets of alleged “science-based” horse manure… errr propaganda. Wake up lefty, the right side of your brain needs some oxygen!
And you can trust Aaron, because as editor of Health Freedom News, he doesn’t have any sort of axe to grind in this area.
Plus he’s really scientific. As an example of how scientific he is, allow me to quote a small item from his HFN of 4/5, about the ingredients in Coke Zero:
As you probably know, being full of chemical names is an infallible sign of horrible toxicity. As is being frowned on by Dr. Mercola.
Newsphlash, Aaron, but Hep B can be transmitted via more routes than just sex. Bites and open sores can also be means of transmission.
I’m no scientician, but I do know how to use The Googles, and I found this:
“Hepatitis B vaccination in infancy in The Gambia: protection: against carriage at 9 years of age”
–http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TD4-3X115S9-2&_user=10&_coverDate=08%2F06%2F1999&_rdoc=1&_fmt=high&_orig=gateway&_origin=gateway&_sort=d&_docanchor=&view=c&_searchStrId=1731548992&_rerunOrigin=scholar.google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=c911ed3ab6eb4ca4ff9cee2a170d0986&searchtype=a
“Efficacy of a mass hepatitis B vaccination program in Taiwan. Studies on 3464 infants of hepatitis B surface antigen-carrier mothers.”
–http://ukpmc.ac.uk/abstract/MED/2971827/reload=0;jsessionid=F57037E6B634FBCFF92F1444ADEF7752.jvm4
“Hepatitis B Virus Infection: Epidemiology and Vaccination”
–http://epirev.oxfordjournals.org/content/28/1/112.short
I found plenty of other studies showing how the vaccine prevents hepatitis in at-risk populations, and how administrering the vaccine at birth reduces liver cancers amongst children, though I’ll agree I didn’t see a lot about vaccination at birth preventing sexually transmitted infection during adulthood, so you might have the germ of a point.
Overall, though, it seems to be pretty definitively demonstrated to have a positive effect with minimal side-effects.
wintermute:
Silly wintermute, can’t you see what Aaron is actually saying? It’s not whether something works, nor how well it works, but whether the person promoting that thing is the right kind of person.
After all, if you’re the kind of person who cares about facts, pure, testable, observable, objective facts – you know, the kind that can potentially disagree with the ideas inside your head – then you’re obviously the wrong type of person, and should be disparaged and degraded.
On the other hand, if you’re the kind of person who will blindly listen to and follow what some random guy on the internet says simply because they use words like “alternative”, “natural”, and “big business” (while failing to acknowledge that they themselves are supporting a multi-billion dollar a year industry), then you’re a freaking Hero! Throw yourself a parade!
OVER A THIRD OF ALL HEP B CASES ARE UNASSOCIATED WITH ANY RISK FACTORS. On top of that getting HEP B as a kid is associated debilitating effects and a shortened lifespan. God almighty. This is the easiest idiocy to debunk and yet this claim always pops up.
Oh goody, Orac is feeding us some new trolls!
@daniel
You must be new around here. Otherwise you would know that Orac is a shiny, plastic box of wires with blinking lights. His only medical condition is constant failure of irony meters.
Only the fox can determine what is good for the chickens. SBM is set up to see to it that they are the only fox in the henhouse.
-Benjamin Rush, father of American Medicine, signer of the Declaration of Independence
wikipedia
-Woodrow Wilson
Big government. Little government. Either way the people don’t own it. The man does. I’d prefer “the man” to own as little as possible.
BTW medical practice KILLS 200,000 Americans per year give or take depending on the source. How many died from supplements last year? Even the bad ones.
You mean the guy who thought that poisoning people with Mercury was a good idea? The guy who actually is a walking textbook example of how one could delude themselves into thinking they are doing good things. The man who if what I read was correct engaged in so much bloodletting that his lawn was a giant scab. Only augustine would cite such a crank.
Yes, augie, we know you’re such an anarchist that you think it’s fine to let sCAMmers lie to and defraud the public at will.
Nobody sane agrees with you.
You know, I really love how alties use negative character attributions and loaded language. Reliable and amusing.
Daniel
Yes, because implicitly no healthy adult would take a flu shot to avoid missing two weeks of work or classes, ill health is punishment for not “living right,” and you gotta love the strawman of pharmaceuticals equalling rat poison.
Aaron
Nice guilt by association. We are not Big Pharma. How do we know Pharma companies sometimes falsify their studies and make exaggerated claims? Oh yeah, scientific studies.
So you can’t dismiss what Orac has written condemning false and exaggerated claims by supplement manufacturers because “Big Pharma does it too!” We are not Big Pharma. Their crimes have zero bearing on evidence againt false claims made for supplements. Both are happy to peddle similar lies, and that does not make your lies okay.
So please, keep howling “pot, kettle, black!” We’re not the kettle. Yes, you’re a crook too, just like the very worst behaviour from your favourite boogeyman. We know.
And saves many more that.
http://whatstheharm.net/vitaminmegadoses.html
There are plenty more appropriate categories there, but that should do for a start.
But, more to the point, how many lives have supplements saved? Is the net effect of supplements better or worse than that of regulated medicine? And how will allowing supplement manufacturors to make unsubstantiated claims improve their safety and efficacy?
Massengill Company – what a bunch of douche bags.
🙂
Scott:
Well, to be fair, blood thinners like wharfarin are used to both prevent heart attacks and to kill rats. Of course, Vitamin D is also used as a rat poison, but that doesn’t stop the alties megadosing on it.
augie:
Did you know that every year hundred of people inhale something that causes major problems, or even kills them? Obviously, the only rational thing to do is to stop breathing right now!
@Aaron
Dr. Mercola = credible source?
Didn’t think so.
So, the “health freedom warriors” want Big Supplement to be able to say anything they want about their products without interference from the FDA. I presume they realise that the FTC is too busy to track down and prosecute the “Whack-a-Mole” supplement distributors who will close up shop after they get an FTC letter and re-open it under a new name in a different state.
It appears that these folks are willing to throw the public under the bus in order to keep the FDA from blocking their profits. After all, if Big Supplement can say “ionised water can cure cancer” (based on a single poor-quality study they commissioned with no oversight), what keeps Big Pharma from doing the same?
Wouldn’t it make more sense for Big Pharma to market their next ED drug direct to the flaccid public rather than spending time and money trying to get FDA approval? All they’d have to do is call it a “supplement”. Just think – they’d have the drug…excuse me, supplement… on the market in less than a year and they wouldn’t have to rely on doctors to prescribe it. They could make a fortune…just like Big Supplement is doing today.
To be frank, I can’t see why Big Supplement wants to rock the boat like this. They’ve done very well financially even though they’ve had to do their advertisement by indirection. The general (gullible) public knows that when the advert says “promotes prostate health” or “essential for healthy sexual activity” that they’re really saying “prevents prostate cancer and prostatic hyperplasia” and “treats erectile dysfunction”. The “quack Miranda” (“Not intended to treat or diagnose any disease. These statements have not been approved by the FDA.”) only serves to emphasise the “wink, wink, nudge nudge” aspect of their claims.
I’d like to make a counter-proposal. I’d be willing to accept HR 1364 if they made one tiny amendment: allow private citizens to bring suit for violations of FTC regulations under the Common Law principle of qui tam [Qui tam pro domino rege quam pro se ipso in hac parte sequitur.] That might put enough pressure on Big Supplement to keep them “honest”.
Prometheus
If I didn’t have to prepare a rather lengthy presentation for tomorrow and investigate an outbreak of a communicable disease, I’d educate Aaron on hepatitis B. Then again, he can just Google it to learn that it is a blood-borne pathogen, not exclusively a sexually transmitted disease. He’d learn that blood transfusions, accidental needlesticks, contaminated medical devices, bites (as Todd pointed out), and contact of wounds with contaminated blood are other ways of contracting Hep B. He would then learn that the vaccine series gives immunity for as long as we can tell. (There aren’t enough people that have had the vaccine for more than 30 years, but those that have had it that long are still immune.)
But why let the facts get in the way of the axe he has to grind, really?
And what can I say about aspartame other than it’s tasty, it allows diabetics to enjoy sweetners, and it should be avoided by phenylkenonurics, a condition for which you are screened when born (in most States) right before they save your liver with the hep B vaccine.
Oh what the heck, augie’s committing the same error.
Science Based Medicine is not Big Pharma. Science is how we know when Big Pharma, and CAM promoters, are lying. You’re deliberately confusing university academics/medical doctors with deceitful company executives.
So let’s correct that guilt by association.
Why do we need two foxes in the henhouse? Ought not we put up some chickenwire and have no foxes in the henhouse?
You and Aaron have convinced me the FDA needs more power to regulate claims made by Big Pharma and supplement manufacturers alike.
@ Aaron & Adam Y: I see that you have pried yourselves away from anti-vax sites and have come to post here with hepatitis B pseudoscience.
Hepatitis B vaccine and HBIG are administered to a newborn whose mother has been tested and is positive for the presence of hepatitis B surface antigen (she is a carrier of the deadly disease). The vaccine and HBIG (hepatitis b immunoglobublin) are administered within 12 hours of birth, to prevent the transmission of the virus to the newborn.
Newborns, prior to the development of hepatitis b vaccine 30 years ago and prior to the institution of blood testing all pregnant women for the presence of the surface antigen, exposed the infant and they became infected with the virus and were lifelong carriers of the virus. Infection in the newborn results in 85-95 % lifelong carrier status as opposed to infection in a healthy adult whose chances of becoming a hepatitis b carrier is ~ 8 %.
Wintermute provided you with some research which you might view as being “too technical.” Here’s a site for you that provides you with all the information about hepatitis B, hepatitis B vaccine, testing for pregnant women and neonate vaccine and HBIG prophylaxis:
Immunize.org Ask the Experts Hepatitis B
If you have any questions after reading this article, post again and we will answer them.
If I view this post with a little more pessimism then normal, I’d say that I can see this “health freedom” eventually leading to a return to a more science based approach. Of course, the path it would take would be ugly and many people would be harmed.
The original laws regulating pharmaceuticals were the result of the public’s backlash against charlatans and snake oil salesmen who were selling harmful products that they claimed had health benefits. It’s be long enough since that was a problem that people have forgotten all about that. However, as the charlatans and snake oil salesmen work to erode these protections, the very problem that the laws where once enacted to prevent will start coming back. The results are going to go from a few people losing their sense of smell from using Ziscam and woo woo doctors being poisoned by their own products, to significant numbers of people being harmed or killed. By then, the supplement companies won’t be the “good guys” anymore and the media will love going after them just the way they love going after big pharma now.
I would predict that the long term result of looser laws now, will result in even stricter laws down the line. So, my advice to the supplement companies is that they are probably in a great place right now, and won’t benefit long term from relaxing the laws as they currently exist.
I hope it doesn’t come to that, but who knows.
What would this law mean for Big Pharma? Would pharmaceutical companies have freedom to share scientific information on off-label uses? They could direct market drugs with any tenuous scientific backing. Think of the increase in sales. Shouldn’t we be checking with the Pharma overlords to see if we should be supporting this bill?
Hey, he IS the father of American Medicine.
The character attack tells me you didn’t like the quote. So attack it’s author.
Ah yes, pointing out how the author was wrong is a “character attack” now.
You keep using that word. I do not think it means what you think it means.
Beamup:
It is augustine writing. He doesn’t know what any words mean.
Yes because getting your information from the CDC website really does constitute psuedoscience. Did you actually even bother to read what I wrote?
Orac should stick to the areas he knows better, biochemically based nutrition simply is not one of them. This particular blog is an uninformed screed pim-, er pumping up the corrupt FDA.
Vitamin and nutrient deficiencies that can benefit from selective, high dose nutrients, not “drugs”, are slowly being recognized in common situations that involve metabolism, enteropathies, other illness and injuries. We’ve had to learn a few of them the hard way, at great, life changing costs, without doctors’ first discovery.
One former Readers Digest author mentioned above is a dangerously biased old quack whose nutrition views appear misinformed,-ing numerous times, with more errors identifiable in the literature every year.
Sorry if this response conflicts with your world view:
âIt aint what we dont know that gets us into trouble, its what we know for sure, that just aint soâ – Mark Twain
[Citation needed]
Orac should stick to the areas he knows better, biochemically based nutrition simply is not one of them. This particular blog is an uninformed screed pim-, er pumping up the corrupt FDA.
Vitamin and nutrient deficiencies that can benefit from selective, high dose nutrients, not “drugs”, are slowly being recognized in common situations that involve metabolism, enteropathies, other illness and injuries. We’ve had to learn a few of them the hard way, at great, life changing costs, without doctors’ first discovery.
One former Readers Digest author mentioned above is a dangerously biased old quack whose nutrition views appear misinformed,-ing numerous times, with more errors identifiable in the literature every year.
Sorry if this response conflicts with your world view:
âIt aint what we dont know that gets us into trouble, its what we know for sure, that just aint soâ – Mark Twain
@ Adam Y: I misinterpreted your prior posting-sorry.
However, “…getting your information from the CDC really does constitute pseudoscience.” Please provide citations that “deviate” from the CDC information site I provided.
prn,
1. Citation needed for FDA corruption.
2. What specifically did Orac say that you disagree with? Where did he say that nutrients did not provide benefit?
I’m amused by how “Father of x” is meant to mean “really good at x”. It’s pure argument from authority; don’t most of us hope things have got a bit better in the last few centuries? Certain personality types would have been really happy in a medieval monastery, looking up whatever Aristotle had to say on a subject as the last possible word. (I assume everyone is familiar with the joke about horses’ teeth?)
And what are your qualifications prn – other than being a smug arrogant know it all with mo evidence.
When I was training to be an EMT (emergency medical technicians), they said that if you ended up in the profession full time, you should get hepatitis vaccinations. I’m sure this was purely because EMTs are fit and attractive, and are more likely to pick up STDs because, well, they’re more desirable. It couldn’t have been related to hepatitis being easy to pick up from infected blood products- far easier than HIV.
Here’s a thought: if you have a legitimate complaint against Orac or the content of scienceblogs, please try not to mix blatantly false and incorrect information with your legitimate problems. It’s hard to take you seriously when you imply that hepatitis B is limited to sexual transmission.
-Benjamin Rush, father of American Medicine, signer of the Declaration of Independence
The “medical dictatorship” quotation is bogus. It is widely circulated amongst medical libertarians who never provide a source for it, for there is none. Thomas Szasz noted in 2005 that “Rush never said any such thing and anyone familiar with the history of psychiatry ought to recognize that the quotation is an obvious fabrication.”
I can’t be arsed looking up the Woodrow Wilson quotation to see if it is any less spurious.
Hey, he IS the father of American Medicine.
The character attack tells me you didn’t like the quote.
I dislike the quote because it’s fictional. Made up by someone as a statement of their belief and put into some dead authority’s mouth; then reproduced a few thousand-fold across the internet by nimrods as a substitute for arguing their case in person.
It’s a change from attributing made-up phrases to Santayana or Churchill or Lincoln.
Good blog. While I’m a psychologist and thus a scientist, I know next to nothing about medicine. It’s helpful to learn about the history of these laws and how they impact our lives.
It’s crazy to think that supplements are regulated in the same fashion as food.
At that point I was confused about why you lumped me in with antivaxers so I was being a bit sarcastic. I am completely in the same boat that you are. Hep B is a nasty nasty disease for kids to get and one of the more stupider diseases to argue against vaccinating. I apologize for the confusion.
Of course, I suppose Mr. Fucetola could argue that he’s not being as disingenuous as I perceive him to be in that most of the supplement hawkers making health claims for their foods or supplements probably do believe them to be true and therefore are not, strictly speaking, lying. That doesn’t mean that such claims shouldn’t be regulated.
While I agree with the overall point that many new drugs/therapies are crap, it truly is the definition of human freedom to let people decide for themselves.
The FDA after all has banned or refused to permit drugs based upon faulty science and politics (see RU48RU486 or Drvocet).
Keep in mind while reading this that I agree that most /new/ drugs have no real ability to make the claims they do, but that is protected under frad statutes which independent of groups or specific products.
I think what I’m trying to say is that in general I agree with the FDA, but that doesn’t mean they aren’t wrong or haven’t been wrong,
Getting rid of them is a step towards real freedom as RU486 & Darvocet are just two examples… so long as you are willing to give the government the benefit of the doubt, you are automatically stuck wit both their answers and non answers….
Uhhh…. Since when in your conspiracy laden mind RU48RU486’s problems the FDAs. The company nearly shut down its production process long before it ever actually attempted to get the drug approved in the United States and France had to stop them.
“…it truly is the definition of human freedom to let people decide for themselves…Getting rid of (the F.D.A.) is a step towards real freedom…”
Why stop there? Eliminate state medical boards and their repressive licensing rules. Anyone should be free to call themselves medical doctors. Stop inspecting hospitals, it’s a restriction on health freedom. Standards for manufacturing drugs? Purely fascist.
The free market will sort things out.
Health Free-dom! Health Free-dom! Yeah!!!
Whenever I hear “high dose nutrients, not ‘drugs'”, I usually wait patiently for the other shoe to drop….
(paraphrase)
Codex Alimentarius will outlaw the supplements that you *need* and *love*: your vitamin C will be reduced to only 60 mg – just like the corruptly devised RDA dictates – like they do in *Europe*- you’ll need a prescription for your vites- like in *Germany*! It’s the NWO FDA Pharma-Marxist threat to your cherished health freedom! Fight the power!
I’ve heard this now for 11+ years over Radio Woo and for several years from Adams( e.g. NaturalNews, 12/29/10); like most woo memes, it has trickled down to the faithful. Codex hasn’t panned out yet- neither have most of the natural cures that “will replace rx”.
Denice (@50), in Europe, they really do crap like that.
Many natural cure “trials” that fail, do not address issues honestly or are patently defective, and then shout down any serious science objections. I am talking about blatant sabotage or misrepresentation (at least, to me) in many medical journal papers that I’ve read.
I can handle negative results fine. I can’t stand faked negatives that poke me in the eye, contrary to known science and reproducible even on the individual level with objective measures. Or known negatives used to contaminate (sabotage) other trials; retinol contamination comes to mind in a number of “pivotal” papers.
It’s one thing to argue potential innocent third parties’ injury, perhaps for an epidemic vaccine with proven safety and efficacy. What Orac pushes here today is interference with life processes for many people, whether or not there is recognition or agreement. That’s wrong, and destabilizing in an already dystopian USA headed off the rails.
Just because some don’t know, can’t or won’t find something, gives them absolutely no right of interference.
B’up@36 Frequent readers here might be bored with my vitamin D – colorectal cancer discussion. So I’ll switch a little closer to the bone with Orac, so to speak, on breast cancer. PMID: 19349547, 19655244
I also might mention that Orac’s retired or deceased pet nutritional know nothings have routinely attacked some nutrition advocates that recommended vitamin D3 at 1000-2000 iu per day, for decades, instead of the fake stuff, 200 iu, or both.
MOB@39
Thanks, I’ve had a lot of delays with the RI citation link blocker, so I am referencing common, searchable examples.
1. FDA corruption examples on safety: David Graham and the Vioxx episode, Robert Misbin and Rezulin, Andrew Mosholder and antidepressant use in children. As I ‘ve mentioned before, FDA restrictions and exclusions on long known nutrients, like pyridoxamine (safer B6) and active folate, L5MTHF, appear to have a corrupt financial basis for special interests who lobby for legal changes and then petition the FDA to block pre-existing competitors, or remove old generic drugs like dessicated thyroid.
2. I disagree with Orac on expanding FDA authority over supplements related to human biology or nutrition, period. I might agree on a fraud claiming human biology relations (several of the commercial vitamins are not direct human biology so wording is tricky, even if I prefer the more natural type isoforms).
Where did he say that nutrients did not provide benefit?
He’s all wet about what constitutes “excess” much less “dangerous”, vs life preserving nutrient requirements for many. He might as well run around with Kevorkian, advocate breatheable air licenses, or just pulling the plug on anyone using more than 1.1 lpm of air.
MA@41-And what are your qualifications prn – other than being a smug arrogant know it all with mo evidence.
MA, I assume you meant “no”, although “mo’ ” might be more accurate since I usually provide more medical science literature links on a per posting average than most responders here.
In answer about my qualifications: apparently the ability to read and comprehend. At least, more than some know-nothings.
Holy crap…I thought that was something you made up to mock them for being in the pocket of supplement makers. It’s hard to believe they’re so blatant about it.
I have to say, Prn is kind of a fun troll. I was getting bored with Augustine and Sid Offitt. They just can’t pull off icy hauteur like Prn can.
I’ll let somebody else do the fact-based takedown. I’m strictly in point and mock mode today.
@52
Can you say “Dunning-Kruger”? I knew you could…
Well, I can’t say it any better than most of you folks, but I’ll say it anyway. When some MD starts ranting about supplements that aren’t FDA approved, I just have to ask…wasn’t Viodox FDA approved? And when they sling the S word (Science) around, I can’t help but wonder why the FDA approves pharmaceutical drugs that only have a 37% success rate — where’s the science there? It isn’t about science, it’s about money, and pharmaceutical companies don’t want the competition from supplements. And MD’s don’t want you to take care of your own bladder infection by going to the store and buying whatever herb combination works for you. They would prefer you pay them $120 for 5 minutes of their time, and pack you with antibiotics that you don’t necessarily need. (You might need them, but not every time, and in the meantime, your body is building a resistance to them.) It’s not about Science, it’s about Economics. As long as my access to “alternative medicine” is regulated by lawmakers and the medical industries that line their pockets, the “freedom” we so love to brag about in this country is a sham. The idea that the populace needs protecting from “quacks” is insulting. Educate your people and trust them to make good decisions; let them live with the consequences if they make bad ones. That’s what I had to do when I realized I married the wrong man. Congress didn’t try to protect me from that bad decision. What’s the difference?
@prn: congratulations, you actually had citations. You’ve outperformed 99% of the trolls that come here and attack Orac or another regular commenter.
However, if we were to take the premise that the FDA needed to be completely shut down due to corruption, we would have to shut down Wall Street, the big banks, the UN, Alaska and all the oil companies.
Essential thing to note, large entities usually do have corruption due to human nature. We could completely shut down the FDA and replace it with 30 different agencies that attempt to keep Americans safe from products, but the corruption would begin again.
Instead, maybe take less drastic measures, offer independent review of pharmaceutical studies, develop robust systems of checks and balances and continue awareness of those systems, insuring them against political retribution and winds.
Or just keep throwing out conspiracies, those are fun, too.
prn,
Thanks a lot for the clarifications and citations. I haven’t had time to look up your references to FDA corruption, but will do so.
You say
In your opinion, should the government regulate supplements at all and, if so, what organization should do that? If not, how do we ensure that a pill claimed to contain, say, 2000 IU of vitamin D3 actually contains that? This has been an ongoing issue with herbal extracts, where (according to Consumer Reports) the contents can vary wildly from brand to brand and sometimes from batch to batch. Also recall the incident where Gary Null suffered vitamin D poisoning from a bad batch of his own supplement powder. https://www.respectfulinsolence.com/2010/04/too_deliciously_ironic_for_words_gary_nu.php
Additionally, recall that some people have attempted to claim that their pills were nutritional supplements when they were, in fact, industrial chelation agents with no nutritional value whatsoever.
@ prn: “Overdoing” vitamins is called hypervitaminosis and can be especially toxic when you overdose on the fat soluble vitamins (A, D, E), which are stored in body fat.
There have been many recalls of vitamins, supplements and “natural” food products, due to some serious bacterial (salmonella and listeria) contamination and toxic levels of heavy metals.
I want the FDA in place to monitor the safety and efficacy of over-the-counter drugs, prescribed drugs, vitamins and supplements.
I suggest that you “bookmark”:
FDA Consumer Updates Dietary Supplements
@ Mephistopheles O’Brien, my brother from the Dark Side:
Funny you should mention the woo-meister supreme! It seems to me that many of his catch-phrases and so-called facts are re-iterated here constantly by the trolling set. Not only the specific “cures” ( vitamin D, resveratrol, mushrooms, “nutrition”, ad nauseum) but wording patterns and “quotables”- “200,000 ( or 600,000) die by doctors yearly”, “tipping points”, “do your homework”, “doctors don’t know nutrition” etc ( there are, unfortunately, many more that I omit to spare the audience pain). Of course, since Null, Adams, and others spread mis-information around like a bad “dose”, if you catch my drift, who knows who actually started the infection.
Raincitygirl @ 54
I have to say, Prn is kind of a fun troll… They just can’t pull off icy hauteur like Prn can.
Thanks, I’ll take that as a backhanded compliment. However, my points are not for fun or trolling. I hope some take my points seriously before they join Chuck. Not Schwab, but that Darwin fellow.
Listening to erroneous medical cant can be extremely dangerous or deadly. I’ve run into it a number of times in the last year or two, even presented with forks in the road or witnessed predicted, -able bad results. I’ve learned to scratch, sniff and do the anaysis for myself and mine. I feel sorry for those less with education, experience and ability.
Yojimbo@55
Can you say “Dunning-Kruger”? I knew you could…
Your bias apparently prevents you from recognizing my referenced points.
MOB@58
In your opinion, should the government regulate supplements at all and, if so, what organization should do that? If not, how do we ensure that a pill claimed to contain, say, 2000 IU of vitamin D3 actually contains that?
With vitamin and minerals, this is not much of a problem in normal circumtances today, with less labor intensive quantitative methods and equipment proliferating. Rigorously enforcing GMP requirements, as a highly protected label, “GMP”, would be a good start.
This has been an ongoing issue with herbal extracts, where (according to Consumer Reports) the contents can vary wildly from brand to brand and sometimes from batch to batch.
This might be a simple problem to limit. The FDA could occasionally publish assay results from a documented sampling protocol at relatively low cost e.g collect numerous batch/seasonal samples, store in N2(l), gang bang assays, attempt to confer/confirm with manufacturer, iterate QA, and post data on the FDA website.
Although people would probably tolerate somewhat wider margins of variance on herbals, large companies would be forced to clear up fast; small ones, reform or disappear. No protracted legal proceedings, no intimidation or force needed for garden variety slop or sleaze. FDA would merely need to maintain its own technical credibility by impartiality and integrity. Oh.
recall the incident where Gary Null suffered vitamin D poisoning from a bad batch of his own supplement powder
This appears to be a generational level incident of stupendous errors, like the BP oil spill or Chernobyl, that shows the safety margin of vitamins – no one died, no societal scars. As I understand it, Null’s contractor erred by a breathtaking three orders of magnitude, 1000x. Most industrial-govt’l safety factors nominally range from under 2, up to 10+ times over the design (worst) case. Even a ten fold mistake on max dose acetaminophen or many drugs would have been tragic.
The primary problem in the Null case that I see is that full damages are too slow in being awarded to (and from) Null and his customers by the primary culprit. This delay allows a sociopathic type of reckless-stupid manager that we also now meet in industry and government, in this case, running a small company, to stay in business. Instead of being flushed by legal due process for torts.
recall that some people have attempted to claim that their pills were nutritional supplements when they were, in fact, industrial chelation agents with no nutritional value whatsoever.
I would have to look at the incident particulars in more detail. Citric acid is an industrial chelating agent, albeit with nutritional value. With some molecules, the line concerning nutrition can get hazy with some surprises awaiting in human metabolism, or bad faith over at the regulators. I don’t want xenobiotics, including some plant extracts, hiding behind nutrition, but I’ve seen enough regulatory abuses, misrepresentations, and rushes to judgement, to be cautious.
lilady @59
“Overdoing” vitamins is called hypervitaminosis and can be especially toxic when you overdose on the fat soluble vitamins (A, D, E), which are stored in body fat.
Imbalanced vitamin A and precursors appear to inadequately described, with retinols and some caretenoids as popular stealth weapons of choice in the adversarial nutrition wars.
Many forms of “toxicity” are in fact poor “standard” chemical balances amongst nutrients that should have been properly researched, then included in our references and education long ago. This especially appears to be the story with vitamin D3.
Many orders of magnitudes (e.g. a factor of 1,000,000+) of premature deaths due to vitamin D deficiency are likely to already have happened over very rare, if any directly attributable, VD3 nutrient deaths.
There have been many recalls…due to some serious bacterial (salmonella and listeria) contamination and toxic levels of heavy metals….I want the FDA in place to monitor the safety and efficacy of over-the-counter drugs, prescribed drugs, vitamins and supplements.
Expensive, time consuming phase III proven safety and efficacy studies are to deal with the likely toxicity and inefficacy of new molecules, including most new drugs.
On food and concentrated nutrients, I would be happy with the FDA unobtrusively checking for purity, promptly outing transgressions, and technically aiding local authorities prosecute real crimes.
Even, or especially, low cost generic drugs with long records of safe, and even superior, uses have been mugged, killed off or extorted, by the 21st century FDA. For many, the FDA has already interfered with life saving materials to a point that the terrorists in our headlines are a smaller personal hazard.
OOo yes use the stupid paranoid conspiracies. It can’t be that some of these chemicals are toxic in large enough doses can it. For fucks sake I have common mineral supplements sitting in my chemistry laboratory that have skull and crossbones on the label.
We shouldn’t be baiting prn…after all her toy chemistry lab is set up on her kitchen table. When she isn’t playing doctor with her play stethoscope and wearing her scrubs in an assortment of colors, she dons her lab coat and sets up the chemistry kit. I bet she also has the costumes for her Barbie and Ken dolls.
This discussion with “prn” highlights some of the common diversionary tactics used by self-proclaimed “nutritional experts”:
Strangely enough, my university does teach nutrition in its medical school and has for over half a century. While the course has not always been labeled “Nutrition” (often being “disguised” in the “Physiology” and “Biochemistry” courses), it has been present for all this time.
Not only is this irrelevant to the issue – “Should the FDA regulate medical claims made by manufacturers?” – but it highlights the fact that the USFDA’s regulatory mechanisms work. Problems that were not detected prior to release of a drug – because of their rarity or because of incompetence or corruption – were picked up by post-release monitoring. This tells us that the system works.
Now, contrast this to what Big Supplement wants to happen. Big Supplement wants to be able to make any claims it likes about its products without any oversight beyond the FTC.
Under FDA rules, Big Supplement has to show that its claims are supported before it can make them; under FTC rules, the FTC has to show that the claims are false before it can take action. See the difference?
When I read some of the…claims made by self-identified “nutritional experts” about how we need precise ratios and amounts of this to that and how the “wrong” form of a vitamin or “mineral” is worse than none at all, I wonder how we ever made it as a species. Seriously, if we were that fragile, it would be Homo sapiens neanderthalensis here instead of us.
Of course, the key weasel phrase is “optimal health”. This is an empty phrase that can be used to rebuff any demand that the “nutritional expert” show that people following their regimen are any healthier than the average Joe eating a balanced (by USDA standards) diet and getting the average amount of exercise. Clearly, “mainstream medicine” isn’t capable of measuring “optimal health”, since it looks just like “good health” to real doctors.
However, by promising “optimal health” – which isn’t a “lack of disease” but some higher plane of “health” which can’t be reached without “optimal nutrition” – the “nutritional expert” can dodge the tough question: “How do you know that your regimen works?”
The real beauty of the nutritional racket is that you can (and should) make the regimen so difficult that almost nobody will be able to follow it perfectly. That way, if someone later comes down with “sub-optimal health” (e.g. cancer, heart disease, diabetes, etc.), you can say, “Did you follow my regimen exactly? No? Well, what do you expect, then?”
Likewise, since the regimens of most of these “nutritional experts” are time-consuming, difficult and – usually – expensive (if not the “supplements” and dietary modifications, then the “evaluation”, “coaching”, testing etc.) – they will appeal primarily to people who are motivated, concerned about their health and well above the median income. In short, the people who generally are healthier than the average citizen.
It’s not that “prn” is a more virulent variety of the self-nominated “nutritional expert” – he/she is only about average, if that. I’ve been hearing the same specious arguments and the same spurious “facts” for decades. Heck, there were booklets about “optimal health through optimal nutrition” ‘way back in the lat 1800’s. Same s**t, different year.
What remains after all of the smokescreen in misdirection “prn” has put up is the simple fact that “prn” hasn’t produced any data showing that all the careful nutritional balancing and all the megavitamin “therapy” actually does anything tangible (i.e. measurable). All he/she can show is that “mainstream medicine” has – based on real, tangible scientific data – increased the recommended intake of a number of nutrients (e.g. folate, vitamin D) and decreased the recommended intake of other nutrients (e.g salt, fats) on a number of occasions. This is a far cry from what “prn” is advocating.
What this Act would do is completely unrelated to “optimal health” unless you are referring to the “optimal health” of the profit margin at Big Supplement.
Prometheus
prn:
You’ve said you want the FDA to have no authority of supplements. And then you say that the supplement manufacturers can be kept honest if the FDA periodically analyzes samples and publishes the results.
In the meantime, between batches, people can die: if the only authority is to publish how much vitamin B-12 (say) is in a capsule, who protects me from the careless manufacturer who puts in belladonna or tetanus toxin? What is threatening about a law that says that if a package says “500 g vitamin C” it must contain that, and that anything sold for human consumption should be made in ways that keep it free from contaminants like lead, mercury, and dangerous bacteria? You may have the right to swallow large amounts of mercury: you don’t have the right to sell it to other people, disguised as a harmless herb, for them to unknowingly feed to their children.
I am prepared to debate (though maybe not here, it’s badly off topic) the right to knowing suicide, and the right to take informed risks. That doesn’t extend to the right to poison strangers for profit.
@ Prometheus: “since the regimens of most of these ‘nutritional experts’ are time-consuming, difficult, and – usually- expensive”
The woo-meisters I review present themselves as the *ne plus ultra* of nutritional rectitude: they lovingly recount the balanced and varied combos of organic foods and juices that they consume daily. In addition, their recommendations for *numbers* of servings per day of say, vegetables and fruits, far outreach those of most standard dietetic authorities ( “They know nothing!” shouts the guru).
If you peruse Gary Null.com, you can click on the “People’s Food Pyramid”** ( @ left). The “Good Food” Pyramid illustrates my point: you need tons of whole grains, vegetables, and fruits to fulfill its requirements. Who, pray tell, eats like this- other than its perpetrator? So, to take up the slack, you can order powdered “greens”,”reds”, and “grains”, along with myriad other supplements ( see “Store”,same website). The “Bad Food” pyramid reveals the real world atrocities and criminal eating patterns of folks like us ( although he left out gin).
Mike Adams advises an impossible to maintain diet and exercise schedule. Mere mortals unable to keep up with this paragon can supplement with his many products. Remember, that both of these salesmen also preach that disease is caused and *cured* by diet ( as well as by “toxins”- but that’s approached in a *slightly* different manner).
** yes, he actually calls it that.
Denise Walter points out (about self-certified “nutrition expert” Gary Null):
Ah yes, the not-so-subtle conflict of interest of selling the products people need to carry out your “expert” recommendations (often “single-source” items, available only from the “practitioner”).
That would be like my doctor telling me that I need to take a drug which can only be purchased in her office “shop”. In most states, that is illegal (not sure about Arkansas).
Prometheus
Adam_Y@62 use….paranoid conspiracies
A lot of problems can easily be ascribed to ignorance, bias and oppositional thinking. Things I see frequently.
lilady@63
Your speculations display a refreshing hostility to even the idea of individuals’ use of, or involvement in, science.
P in the Darkness@64
When I read some of the…claims made by self-identified “nutritional experts” about how we need precise ratios and amounts of this to that and how the “wrong” form of a vitamin or “mineral” is worse than none at all,
pfffffftt. There are “wrong” forms, and less optimal forms of vitamins. Even the pharmas can tell you that.
Results with K3 at high dose can be much different than K2. Earlier D1 if you can find it, much less D2’s historical problems. Some pharmas have taken pains to capture the more effective, or safer, vitamin forms as prescription items (e.g. L5MTHF, pyridoxamine) and remove them from common commerce and OTC. However, some pharmas are also happy to take truly dangerous vitamin forms that are notoriously toxic or cause birth defects, and sell them to kids as an expensive drug.
Medically therapeutic vitamin D3 blindly dosed up to low toxicity is largely a failure to understand or apply the concept of Ksp with the enhanced absorption of calcium. OD’ing on calcium (or phosphorus) is a serious imbalance from ignorance.
will appeal primarily to people who are motivated, concerned about their health and well above the median income. In short, the people who generally are healthier than the average citizen.
Outside of sports nutrition, I would say appeal to people who are out of (acceptable) conventional medical options, are my experience. I’ve personally heard two such “death sentences” in the last several years.
These certainly convinced me to pay extra attention to technical opportunities in biochemically oriented, therapeutic nutrition. The first “sentence” has been demonstrated to be wrong by longevity and improvement rather than decline and extinction. The second “sentence’s” schedule is fast approaching its prognosed “doomsday”. May be I better go check the tires and lightning ties.
Vicki@65
What is threatening about a law that says that if a package says “500 g vitamin C” it must contain that,
Absolutely nothing, such laws have been around for millenia and are foundational. The FDA would be in great shape if it did this unobtrusively with less partisanship and interference.
the right to knowing suicide, and the right to take informed risks. That doesn’t extend to the right to poison strangers for profit.
You missed it. My earlier answer(@ ) to MOB@ exlicitly addressed the expectation of societal redress against any misanthropic claim of a “right to poison strangers”, across several millenia.
My “analyze and publish” suggestion is simply for a low cost control, a cost effective speed bump. I don’t mind FDA having the authority to rigorously protect the “GMP” label – FDA just needs to quit whining, goofing off and playing politics, demanding ever more powers. I don’t think the FDA should have the ability to be a self dealing rule maker, assailant, judge, jury, and executioner the way it has been.
Many also don’t appreciate others, like FDA, trying to “suicide” them or theirs, by interference and distraint.
In response to my comment:
“prn” retorts:
Nice try, but the full comment was about the claim that taking the “wrong” form of vitamins was worse than no vitamins at all. So, if I take ascorbic acid (vitamin C) rather than “ester-C”, will it be worse than taking no vitamin C at all? No.
Then “prn” goes off on a tangent about overdosing on more potent forms of a few vitamins or taking too much of certan “minerals” (e.g. calcium or phosphorus), which is completely irrelevant.
Yes, overdosing is “bad” for you, I agree. However, there is no truth to the claim that taking ascorbic acid instead of “ester-C” or hydroxy-B12 instead of methyl-B12 is worse than getting no vitamin C or vitamin B12.
Nice try, “prn”, but I’m very familiar with the “straw man” type of argument. I’ll assume that you agree with the rest of my points, since you didn’t bother addressing them.
Prometheus
prn states in her triple postings (# 34, #35 and #37) “Orac should stick to the areas he knows better, biochemically based nutrition is simply not one of them….This blog is an uninformed screed pim-, er pumping up the corrupt FDA”.
When asked for citations, prn supplies none of them…but proceeds with her screed-like unintelligible repetitive postings.
prn, all the information about dietary “supplements” is contained in the NIH-ODS (National Institutes of Health-Office of Dietary Supplements) Fact Sheets available at:
NIH ODS
Merely type in the vitamin, mineral or supplement you are looking for and voila the complete extensive Fact Sheet appears. The Fact Sheets include availability of the “natural” vitamins, and minerals in foods, the homeostasis of body functions associated with the vitamins and minerals, situations where a given person may have deficiencies and problems with “overdosing” on these vitamins and minerals. The Fact Sheets also have citation links…dozens of them, from international studies.
What prn doesn’t realize is that the bloggers here (trolls exempted), have a science background, some are even self-educated in the sciences. Many of us are medical doctors, nurses, biologists and researchers but we all have the ability to research “nutritionists” “dietary supplements” and any and all purveyors of junk science.
P in darkness@69, ref@64,
I mentioned that there are problematic vitamin forms. You breeze by with a meaningless vitamin C example that is not problematic. BFD. There are (bad, inappropriate) forms that DO leave people permanently damaged, worse off than not taking them. Some were EMBRACED by the pharmaceuticals and medical profession for various purposes with big bucks, anyway.
The example of Ksp for Ca-P vitamin D3 example, shows a medical taboo of undescribed “toxicity” that might be ascribed to incompetence at the high school chemistry level. Correct balance on calcium for any vitamin D intake, extends its therapeutic range for correct use. Many supposed supplement “test failures” clearly reflect a similar lack of skill or objective design.
I’ll assume that you agree with the rest of my points, since you didn’t bother addressing them.
Nah, just a dismissive, ill-informed screed with a personal attack trying not to communicate or acknowledge anything, probably boring everyone else. I am not trying to write a whole textbook for slow learners, rather just alert any real skeptics’ thinking here.
Tell me, prn, did it ever occur to you that if you make a claim, you have to provide the evidence supporting it?
Thanks, GF. We’re getting there. I do provide some references to my points. Let’s see if PnD even knows the words, first.
@prn: Promethius and other posters here do not bore me…they actual use real science. Now you on the other hand, have the ability to construct sentences and paragraphs with nary an aim in sight. Do you even know sentence structure and how a paragraph should be constructed? Do you even know how to provide citations…or does your knowledge of nutrition come from internet sites?
prn, this is a grown up site…I suggest you go to other sites on the internet. But, first consult a textbook to learn how to write cogent, literate sentences.
BTW, wanna play liar’s poker? What are your credentials for writing about nutrition?
lillady@70
prn, all the information about dietary “supplements” is contained in the NIH-ODS
I sure found a lot of blank pages.
Some of what I did find disagreed with expert groups from other countries with more national interest in the subject, e.g. Canada for vitamin D.
After spotting superflous praise for the doubtable Mr Barrett, I noticed some the thin material presented was familiar, either a plagerized looking form from Quackwatch, or vice versa.
What prn realizes is that many bloggers here have no inkling about actual therapeutic nutrition, recycle cant (and “can’t”), couldn’t save themselves if they had to, are eager to pontificate on unresearched drivel, and promote interference with those that can.
âThe person who says it cannot be done should not interrupt the person doing itâ-attributed to chinese proverbs
Dr. Orac,
I’m willing to debate with you the proposition that properly prescribed, FDA-approved drugs kill more Americans than most diseases… oh, but there’s no reason to debate what is already well known — at least a hundred thousand die yearly from pharma-drugs*. However, if you’d like to debate the issue, I’m pleased to invite you to be our guest on Dr. Rima Reports (Sunday mornings, Oracle Broadcasting). Maybe Tim Bolen would volunteer to be the moderator for the debate.
In any event, no one is forcing you to take any supplements; in fact, please don’t take any. Wouldn’t want you to tilt the stats, which are, to repeat:
– Deaths due to properly used DSHEA products: 0
– Yearly deaths due to properly used, FDA-approved drugs: 100,000+
Medical “Science” – doing its bit for Global Depopulation…
——————
* “The JOURNAL of the AMERICAN MEDICAL ASSOCIATION (JAMA) Vol 284, No 4, July 26th 2000 article written by Dr Barbara Starfield, MD, MPH, of the Johns Hopkins School of Hygiene and Public Health, shows that medical errors may be the third leading cause of death in the United States.
The report apparently shows there are 2,000 deaths/year from unnecessary surgery; 7000 deaths/year from medication errors in hospitals; 20,000 deaths/year from other errors in hospitals; 80,000 deaths/year from infections in hospitals; 106,000 deaths/year from non-error, adverse effects of medications – these total up to 225,000 deaths per year in the US from iatrogenic causes which ranks these deaths as the # 3 killer. Iatrogenic is a term used when a patient dies as a direct result of treatments by a physician, whether it is from misdiagnosis of the ailment or from adverse drug reactions used to treat the illness. (drug reactions are the most common cause).”
http://www.cancure.org/medical_errors.htm
Dr. Orac,
I’m willing to debate with you the proposition that properly prescribed, FDA-approved drugs kill more Americans than most diseases… oh, but there’s no reason to debate what is already well known — at least a hundred thousand die yearly from pharma-drugs*. However, if you’d like to debate the issue, I’m pleased to invite you to be our guest on Dr. Rima Reports (Sunday mornings, Oracle Broadcasting). Maybe Tim Bolen would volunteer to be the moderator for the debate.
In any event, no one is forcing you to take any supplements; in fact, please don’t take any. Wouldn’t want you to tilt the stats, which are, to repeat:
– Deaths due to properly used DSHEA products: 0
– Yearly deaths due to properly used, FDA-approved drugs: 100,000+
Medical “Science” – doing its bit for Global Depopulation…
——————
* “The JOURNAL of the AMERICAN MEDICAL ASSOCIATION (JAMA) Vol 284, No 4, July 26th 2000 article written by Dr Barbara Starfield, MD, MPH, of the Johns Hopkins School of Hygiene and Public Health, shows that medical errors may be the third leading cause of death in the United States.
The report apparently shows there are 2,000 deaths/year from unnecessary surgery; 7000 deaths/year from medication errors in hospitals; 20,000 deaths/year from other errors in hospitals; 80,000 deaths/year from infections in hospitals; 106,000 deaths/year from non-error, adverse effects of medications – these total up to 225,000 deaths per year in the US from iatrogenic causes which ranks these deaths as the # 3 killer. Iatrogenic is a term used when a patient dies as a direct result of treatments by a physician, whether it is from misdiagnosis of the ailment or from adverse drug reactions used to treat the illness. (drug reactions are the most common cause).”
http://www.cancure.org/medical_errors.htm
“Doing its bit for global depopulation”? What color is the sky on your planet? On mine, the population is steadily increasing, as is individual life expectancy. (Not always the same thing, of course.)
@Ralph
Tim Bolen? You’ve got to be kidding. If you wanted me to accept any invitation, mentioning Tim Bolen was a perfect way to guarantee that I’d tell you to take a flying leap. In fact, I’m doing just that right now.
I do thank you, though. I’ve perused your website. I do think it will be fun to march my way through the rank quackery that you feature there over time. Never let it be said that I don’t appreciate a good blogging lead.
Ah, the Starfield paper gets cited again. The phrase “lies, damn lies, and statistics” comes to mind.
Let’s say there’s a hypothetical medication which is used to stabilize heart rhythms in patients having severe heart attacks. It has a rare and unfortunate side effect in .01% of patients who prove to be fatally allergic to it. In a given year, this medication is adminstered to 1,000,000 people who are having what would otherwise be fatal heart attacks.
Under Starfield’s counting methods, the medication is responsible for 100 iatrogenic deaths, rather than for saving 999,900 lives.
You’ve gotta view Ralph’s puffery on LinkedIn and WikiUser.
Notice that the link Ralph provided has articles from newspapers and “cherry-picked” articles from medical journals about the COIs some doctors have with drug manufacturers. See Ralph’s COIs on LinkedIn and WikiUser; he couldn’t resist putting in the long list of his board affiliations with natural supplements companies. Go for it, Orac.
Fielding
Except it’s not. It’s given to people who doctor’s “think” might someday maybe possibly somehow have an otherwise fatal heart attack. It changes the context into something more realistic.
And… Are there 1 million fatal heart attacks per year? I don’t think so. Are there 1 million saved from hypothetical heart attack medicine per year? I don’t think so.
Little Augie word fail, he does not know what “hypothetical” means.
Mr. Chris,
Killfile fail
I don’t use a killfile, because sometimes I see and an amused by your total fails. But I mostly ignore you.
You’ve implied that you use killfile and you’ve suggested it for other’s restraint for commentary. Perhaps you don’t have the restraint yourself. There’s an overriding need to “be right”. You just can’t help yourself.
@ prn: What site did you visit? I gave you directions to type in the vitamins and minerals you were talking about at NIH ODS?
How about some citations from you…or do you just make it up in your head?
How about playing some liar’s poker by providing the citations that we have asked for. And, tell us what courses you have taken in college and beyond…and what your professional credentials are, as well.
Mr. Chris, not a doctor but a rocket scientist
@lilady
Looking at ralph’s wiki user page, and the edits he made especially to the Nicolas Gonzalez page, it’s not surprising that he would have a major COI.
Since this thread seems to be still alive, I am still hoping for a defense of the claim (comment #16) that Benjamin Rush is the author of a made-up passage about medicine and “undercover dictatorship”.
The unfortunate thing is that the proposed debate calls for the powers of none other than MC Natal Cleft, who is nowhere to be found.
Obviously it takes boring troll a few days to recover after spouting of bogus quotes – almost like it needs to recharge its crazy before coming in again (and forgetting the fact that it’s been proven wrong time and time again).
Apologies to regulars here, as I have brought this up before, but it bears repeating I think.
Ralph – how many people’s lives do you think are saved by medical treatment? How many of those who die from iatrogenic causes would have died without any medical treatment? The vast majority of iatrogenic deaths are in people who are very unwell. Of course we should be making greater efforts to reduce this number, but the figures you quote make it sound as if huge numbers of healthy people are being slaughtered by incompetent doctors. The truth is that deaths from medical errors in relatively healthy people are unusual enough to make newspaper headlines.
Claiming that “properly prescribed, FDA-approved drugs kill more Americans than most diseases” is simply wrong. Cardiovascular, lung, and blood diseases alone kill more than a million Americans every year. The reason that no one is killed by “properly used DSHEA products” is that they have very little effect at all. Life-saving drugs do have effects, some positive and some negative.
To return to the example Antaeus Feldspar used earlier, deaths from coronary heart disease in the USA declined from a peak of 476 per 100,00 in 1963 to 163 per 100,000 in 2003. To quote an analysis of the Framingham Study, “Increased use of aspirin, Ã-adrenergic receptor blockers, ACE inhibitors, and lipid-lowering therapy in patients with chronic CHD, greater use of antiplatelet and thrombolytic treatment, and coronary revascularization are believed to be responsible for reductions in acute myocardial infarction mortality and CHD death.”
A study in Scotland concluded that 40% of the reduction in CHD deaths they recorded between 1975 and 1994 were due to improved treatment, and 60% to risk factor changes.
If cardiovascular deaths had continued at the 1963 rate, there would have been 1,399,644 deaths from CHD in the USA in 2003. In fact there were 479,290, a reduction of 920,354. Assuming 40% of this reduction in deaths was due to treatment, that means that more than 300,000 deaths are saved every year by treatment for CHD alone. This is a rough, ball-park calculation, but is probably not too far from the truth.
Add to that the number of lives saved by antibiotics, vaccinations, trauma surgery, insulin treatment for diabetes, heart, lung, liver and kidney transplants, dialysis and a large number of other interventions. The number of lives saved by conventional treatments absolutely dwarfs the number of iatrogenic deaths. Great efforts are being made to reduce the number of iatrogenic deaths by using checklists, infection control measures, and computerised flagging of drug interactions, to name but a few, but to suggest, as you seem to, that modern medicine is so dangerous it should be abandoned in favor of popping supplements seems utterly ludicrous to me.
Under Starfield’s counting methods, the medication is responsible for 100 iatrogenic deaths, rather than for saving 999,900 lives.
Little Augie:”You’ve implied that you use killfile”
Evidence? I do not use a killfile, I just skim over your inanity. Sometimes I catch a glimpse of your incredible stupidity.
Oh, good grief. Little Augie still doesn’t know what hypothetical means!
It’s lovely May day with glorious sunshine- so here I go wrecking it for you: is the following as bad as taking blood from children at a birthday party to support your project- or is it worse because, although it is not as invasive, it involves more children and a more insidious ( and non-SBM) intrusion into people’s lives?
A well-known woo-meister has insinuated himself – and his ideas- into a Charter School** where poor, African-American children attend. Under the guise of a nutritional approach to blood sugar control and learning disabilities, he has managed to talk parents and staff into a 4 month “total life style change” for *both* the adults and children ( over 400, I believe). Repeating the format of his many previous “health support groups”, the subjects are instructed to go vegan, organic, exercise more, etc. Various measures are taken. Filming has occured.
Presenting himself as an “international expert”, he rents rooms at places like the UN and Rutgers University to give “keynote speeches”- and decorates his website with information about these events and his “professorialism” (he does give an internet course @ FDU). Then, he recounts his many successful “studies” that support his spurious ideas: I’m sure that these self-advertisements might influence parents and staff who sincerely would like to improve children’s and their own lives. A representative from the school spoke about “great results” subjects experienced with weight loss, blood sugar, and ADHD, LD. ( radio 4/29/11).
As Orac discusses how woo infiltrates med schools, I have encountered actvities like the above which affect young students -some target Charter Schools because there is less governmental and administrative “interference”. Adams similarly gives $1000 rewards to schools who follow his lead towards natural health via his charity.
A certain word comes to mind, but I believe I am too white to say it .
** Gray’s Charter School, 55 Liberty, Newark,NJ
I used a hypothetical medication because my point was the flaws in Starfield’s counting methods, not the exact benefits of a specific medication.
But since Goofus doesn’t like our hypothetical, let’s use the real-world example of insulin. Consider the following fairly undeniable facts about insulin:
1) A large number of people are dependent upon insulin to live, and will suffer and die if they don’t get insulin injections at the proper times. Call this population X.
2) A very small fraction of insulin-dependent people die because of insulin, possibly because insulin was injected at the wrong time or in the wrong dosage. Call this population Y.
3) If insulin did not exist, everyone in population X would die due to its absence. Therefore, even if we subtract Y from X, we still conclude that a very large number of lives are saved by insulin.
4) However, Starfield’s counting methods would assess the effect of insulin by completely ignoring the very large population X of lives saved by insulin and counting only the population Y.
I fully expect Goofus’ response to be shamelessly stupid, something along the lines of “How do you know that there’s actually anyone in population X? The only way to prove that someone would die without insulin (or heart attack medication, or a parachute) is if they do die! Even if you count ten thousand people who died because they didn’t get their insulin, maybe the next ten thousand people with the same condition would magically live without any of that nasty medical intervention! You don’t have a crystal ball to prove that even the most predictable result of a course of action would actually occur, if the steps to keep it from occurring were taken!”
Thankfully, we live in the real world, where we can examine past experience and reason about it to plan for the future. There are ways to do this wrongly, however, and one such way is to assess a course of action based only on its possible benefits or its possible drawbacks, rather than weighing the two against each other. That is the mistake Starfield makes, though not the only one.
A similar example is penicillin, which when first introduced was used only in the most desperate cases, where all medical experience said the patient would die (it was too rare to be used on those who might recover without it). It was incredibly effective and saved many lives, but some people are allergic to it and so it likely killed some of them.
A similar example is penicillin, which when first introduced was used only in the most desperate cases, where all medical experience said the patient would die (it was too rare to be used on those who might recover without it). It was incredibly effective and saved many lives, but some people are allergic to it and so it likely killed some of them.
While Gray Falcon and I still wait for PnD to organize errant thoughts for meaningful repartee or rechallenge, let’s reconsider Orac’s original challenge:
“health freedom” really means freedom for
quacks[former medical believers] from any pesky laws and regulations that would prevent them from staying alive.How is that “reconsidering”? Here, I’ll “reconsider” your words in turn, prn:
“health freedom”free-range lunacy really means freedom forformer medical believersloudmouth crackpots from any peskylaws and regulationscommitment proceedings that would prevent them fromstaying aliveposing a danger to themselves and others.If you have nothing to offer in support of your argument besides bare assertion, I don’t know why you’d even bother, as you aren’t going to convince many people that way.
My “reconsideration” of prn’s words:” Health freedom really means free enterprise”.
AF: It wasn’t a bare assertion, it was an invitation to retrack the discussion toward the original topic, but to consider such laws with respect to actual, infringed upon consumers.
Who consistently exceed doctors’ expectations. Who hit the doctors with papers from national institutes with critical (to them) advances and simple requests, and only get those “Huh?” or “Ha” sounds. Even the “experts”, whose expertise apparently only extends as far as the P,G,R,M feed troughs, rather than their own journals.
@ prn: You are the one who went off the rails…we’ve tried to get you to refocus on the debate of Health Freedom. Rather than providing us with any citations, we are assailed with your aimless inane brain droppings.
At this point, we would settle for just one measly citation from any of your “sources”.
Please get a grip.
Health freedom is a laudable goal, but the big supplement trade groups are not supporting HR 1364:
http://www.nutraingredients-usa.com/On-your-radar/Health-claims/Free-Speech-About-Science-is-admirable-but-could-it-re-open-DSHEA-to-amendments
It isn’t difficult for companies to convey information about supplement research (as long as they follow some rules). I can open any issue of Life Extension magazine and read articles explaining the science supporting various supplements. An article on the health benefits of (for example) blueberry extract will typically be followed a few pages later by an ad for LEF’s blueberry extract product. As Bill Sardi suggests, a bigger problem is the FDA’s lax enforcement against companies making false, exaggerated claims for their supplements. This undermines public confidence in the entire industry.
LL@70: screed-like unintelligible repetitive postings
You have trouble with long sentences, and I do tend to run on. You have extremely limited technical responses, or apparent experimental science capability. Your challenges seem more socially cued and deficient on an elementary level for basic science knowledge. Some of your posts project so many erroneous assumptions, including about me, I hardly know where to begin with your fishing and braying.
LL@70, 74: How about some citations from you…or do you just make it up in your head?….Do you even know how to provide citations.
I’ve been toying with brief, non-link based references since RI has a link blocker that has trashed many previous conversations. Achieving brevity in a convincing way in an adversarial forum with trollish “skeptics” is difficult. I think I like PMIDs best so far.
LL@105 At this point, we would settle for just one measly citation from any of your “sources”.
Some here try to play fair, and many don’t. Today, my focus is, “what about knowledgeable pts who want full access to nutrients” The conversations so far haven’t come close enough to a focus to merit another citation. Sorry LL, you just don’t acknowledge or understand anything.
My thanks for these earlier acknowledgements:
@57 @prn: congratulations, you actually had citations. You’ve outperformed 99%…-JayK
@58 prn, Thanks a lot for the clarifications and citations… – MOB
Fact is, pseudoskeptics, and paid help, almost never concede a point. We all remember Monty P’s black knight, and it applies to all sides.
Yes, I am the self-proclaimed “Queen of Run-on Sentences”…I declared that myself…on Orac’s blog about Grammar Nazis.
Still waiting for measly citations, prn. And, you again change the subject and your focus for today.
How about laying liar’s poker by providing us with citations and your field of study as well as your credentials in the field of nutrition?
Does Stubblebine still hold spoon bending parties like in the old days, with Hal Putoff, Russell Targ, Ingo Swann, and Uri Geller?
“prn” (#68) gives the following “example” of how the “wrong” form of a vitamin is worse than none at all:
Setting aside the fact that the phrasing is unclear and clumsy, let me ask the inimitable “prn” how someone taking an overdosage of one form of a vitamin supports the claim – made in myriad advertisements – that “taking the wrong form of vitamins or minerals is worse than taking none at all” (also, see my comment #64)?
As I see it, what “prn” is saying is “Taking an overdose of one form of a vitamin is worse than taking the proper dose of a different form.” – a statement I can heartily endorse.
I should also point out that – with a few exceptions – it isn’t doctors (at least, not “mainstream” doctors) who are advising patients to take an overdosage of vitamins.
In addition, I also fail to see how “OD’ing on calcium (or phosphorus)” supports the argument “prn” is supposedly making (i.e. that taking the “wrong” form of a vitamin or mineral is worse than taking none at all). With the possible exception of taking something like calcium arsenate or mercury phosphate, a proper dose (or even an inadequate dose) of a (non-lethal) calcium and/or phosphate supplement would be better than none at all.
Obviously, taking a sustained overdosage of vitamin D leads to hypercalcaemia, but I don’t think you can lay the blame for that on the “wrong” calcium supplements, since hypercalcaemia is seen even in the absence of calcium suplementation. And I don’t think that the problem is a “…failure to understand or apply the concept of Ksp…” (Ksp = solubility product constant). It seems that “prn” is conflating some concepts here. At the very least, he/she is not being clear.
“Vitamin D” sold in shops is either D2 (ergocalciferol, made from yeast) or D3 (cholecalciferol, made from wool fat – I’m not making this up) or – less often – a mixture of both. And while there is some controversy over whether humans can utilise D2 as effectively as D3 (or at all), there is little argument that D3 is more readily utilised. I’m still not seeing the contribution of Ksp, since the two forms are practically identical and the differences (one double bond and an extra methyl group on D2) shouldn’t change their solubility enough to make Ksp a factor in overdosage.
Where Ksp might come into play is in calcium supplementation, since many calcium salts are relatively insoluble in water (see: hard water scale). Still, I’m not seeing the part where the varying Ksp’s of calcium supplements are indicators that a proper dose of the “wrong” supplement would be worse than no calcium at all.
Perhaps “prn” can put aside the middle school taunting and address the question at hand. Or not – he/she seems much more interested in telling us all how “stupid” we are.
Prometheus
The health claims the walnut growers were making were solidly supported by third-party peer-reviewed research.
They were certainly on sounder ground than the claims that Frito-Lay makes about its “heart-healthy products.” But the FDA has no problems with the idea that potato chips and Fritos are “heart-healthy.”
Yep, we are indeed witnessing the power of money in Washington. But is it the all-powerful walnut and vitamin lobbies who are calling the shots?
Or maybe–just perhaps–the situation we presently have is one where Ag giants like Archer-Daniels-Midland and Big Pharma already have the FDA in their pockets?
Naw. The FDA bases all of its decisions on the best available science. And if you leave a tooth under your pillow, the Tooth Fairy brings you a quarter.
1. Would you care to provide a citation and maybe a little more background for that walnut claim, David?
2. You do realize that there is a world outside the US, right? You know, there are places where the FDA doesn’t have any power or influence. You’d need a global conspiracy, and, despite what Hollywood tells people, global conspiracies just aren’t tenable. Administrative costs and logistical problems go up very quickly when you involve more people.
3. You also realize that a lot of these people you’re supporting have followers who come by places like this and scream for some rather one-sided deregulation, right? We’re typically the sort who want all corporations to be treated according to a uniform set of standards, whether they’re Big Pharma, Big Supplement, or Big Placebo. The real problem a lot of alties seem to have is that Big Pharma corporations is more willing (but still not always) to play within the rules of science than altie corporations. I don’t know about you, but I think a fox kept on a decent leash is more trustworthy than a fox constantly demanding unlimited free access to the hen house.
The bottom line is that this “science” blog is in favor of big pharmacy companies, and wants to attack their competition.
The case of red yeast rice is a perfect example of a perfectly useful and helpful and SAFER supplement for helping to keep cholesterol in reasonable range. The Chinese have used red yeast rice for centuries, and it is a common ingredient in many Asian foods and recipes. It’s used to give Peking duck its characteristic red color and can also be an ingredient in fish sauce, fish paste, and rice wine. Red yeast rice is used in traditional Chinese medicine as a remedy for poor circulation, indigestion, and diarrhea.
Red yeast rice contains naturally-occurring substances called monacolins. Monocolins, particularly one called “lovastatin,” is believed to be converted in the body to a substance that inhibits HMG-CoA reductase, an enzyme that triggers cholesterol production. This is the way the popular statin drugs work. In fact, “statins” are really just an artificial, expensive rip-off of natural red yeast rice.
Many scientific studies have been performed on the efficacy of red yeast rice AND the dangers of the big pharmacy versions of statins, which often adversely effect the liver and muscles. Yet, the FDA came to the rescue of the big pharmacy companies that they really report to, and they sought to call red yeast rice a “drug”–and to ban the over-the-counter sale of any red yeast rice products containing monocolins. Red Yeast Rice was clearly putting severe pressure on drug company profits and the FDA lapdogs jumped to their rescue.
But the fact remains that red yeast rice is FAR more effective AND SAFER than any statin drug–which is why the drug companies consider it so dangerous to their profits.
This so-called “science” blog, serving the pharmaceutical industry, could care less when the FDA approves dangerous drugs, like the statin drug, Baychol–which has killed many people. They are delighted with the status quo, as long it’s profitable for the drug industry. And if they can force food and supplement manufacturers of healthy products to have to shut-up about the scientifically proven health benefits, that can only HELP to promote unhealthy consumer dietary habits–which, of course, only means MORE PROFITS for the pharmaceutical industry, as they address the “health problems” that they, themselves promoted!
PS: I don’t expect you to post this message. It interferes with the lies you tell.