Mar 21 2013
At Your Own Risk
You are currently browsing comments. If you would like to return to the full story, you can read the full entry here: “At Your Own Risk”.
54 Responses to “At Your Own Risk”
Leave a Reply
You must be logged in to post a comment.
This segment about complementary medicines aired on the ABC tonight:
http://m.youtube.com/watch?v=nH8GwjLZ9IE
Spot on, don’t you think
Unfortunately, no matter how often this information is reported, supporters/believers will only respond with sneers and snorts to the effect that the FDA is the suspect party in this “debate”. They will run on about Vioxx and …wait for it…thalidomide as evidence that the FDA is the culprit in the regulatory picture.
Every article I read in the NY Times and every post Marion Nestle makes on her blog about supplements being loosely regulated, brings a flood of anti-FDA comments. The level of misinformation about supplements and the role of the FDA, to say nothing of the real role of “BigPharma” in all this (that is, the difference between the criticism of someone like Ben Goldacre and the criticism of a Mike Adams) is stunning.
The bright spot is that last time I offered a rebuttal I got hundreds of votes while my legion of attackers got only a few each! Just an anecdote, alas, but it helps me to keep trying.
@ Janet,
Knowledge of thalidomide is my litmus test for whether or not someone really wants to understand the ins and outs of the FDA, as any honest critic would acknowledge both their successes and failures. Are there seriously people claiming it as a failure?
I have looked at several sites selling supplements and I cannot see DMAA listed as an ingredient in Jack3d. Can you clarify this matter please. Is DMAA in Jack3d?
@Earthman,
Here’s the Jack3d label. It definitely does contain DMAA. http://www.jack3d.org/ingredients
Sawyer:
Yes. It is a very good indication of their knowledge of history. Recently comments at the blog of Dr. Gorski’s “friend” there have been claims that the MMR is dangerous because the government claimed thalidomide was safe, and someone was pushing a book where it was claimed that it was that it was only because of “bureaucratic delay” that the USA was saved from thalidomide.
I think knowing about thalidomide is a good litmus test. I read about it
in Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation.
HeHe – “bureaucratic delay” is essentially true. The problem is people’s inability to see a “bureaucratic delay” as a good thing.
One anecdote doesn’t prove DMAA caused anyone’s death. No connection has been established. If I told about my positive experiences with supplements my comments would be dismissed as unscientific and irrelevant. There is some disagreement about whether DMAA is a legitimate dietary ingredient:
http://www.nutraingredients-usa.com/Research/DMAA-not-in-geranium-says-yet-another-study
Instead of simply issuing warning letters the FDA could immediately remove DMAA from the marketplace for any of three reasons:
1. It was determined DMAA is actually causing serious adverse reactions.
2. The agency decided DMAA is not a legitimate dietary ingredient and therefore not a legal supplement.
3. The agency determines no New Dietary Ingredient application has been filed, with safety data included. This would make any product containing DMAA adulterated and therefore illegal.
The FDA cites reasons 2 and 3 in its warning letters about DMAA. This makes the issue one of enforcement, not regulation. Why is the agency taking so long to act?
Chris gave his recommendation for a book about the FDA. Here’s mine:
http://www.amazon.com/Fight-Your-Health-Exposing-Betrayal/dp/1933927178/ref=la_B001K8VWX0_1_3?ie=UTF8&qid=1363887465&sr=1-3
MTR, that “bureaucratic delay” was Dr. Kelsey insisting on seeing some specific animal tests, especially after “she developed an interest in teratogens and earned her Ph.D. and M.D”> in Chicago. The actual “delay” was Richardson-Merrell not providing the requested information and wasting everyone’s time by badgering her.
Jeff, you should read the NYT article linked in Jann Bellamy’s post. It’s quite interesting. This is not a matter of a single anecdote.
The publisher of your linked-to book (Truth in Wellness) sounds awesome. Any publisher with “truth” in its name must really, really want the truth, and I bet it’s not at all a marketing gimmick.
Have you contacted your congressperson to support a more stringent separation between government and industry, for the FDA to have more resources and authority to exercise their oversight mandate? Also, the book seems to be about criticizing the oversight of the FDA regarding drug companies. Bar the fact that drug companies manufacture supplements, what does it have to do with the regulation of supplements? Unless you are advocating for supplements to have the same degree of oversight and proof-claims required of drugs, which I would heartily endorse.
Noting that the FDA is less than perfect certainly justifies a stronger, more independent agency with less influence from industry. Certainly it does nothing to indicate supplements are harmless or effective.
@ Jeff: And…here’s my link to the author of your book, who is the owner of a MLM supplements company and a “Board Certified Nutritionist”.
http://www.wellnessresources.com/supplements.php
He’s not a Registered Dietician is he?
Comparing a “Board Certified Nurtritionist” to a Registered Dietician is similar to comparing a “toothologist” to a dentist.
http://www.youtube.com/watch?v=uRqB5-egs1s
Lilady: Wellness Resources sells supplements, but is not an MLM company. My understanding was that nutritionists and dieticians are in somewhat different professions, with one not necessarily inferior to the other:
http://www.anh-usa.org/campaigns/monopoly-over-nutritional-therapy/
@ Jeff: Check out Wellness Resources “Affiliate Program”:
http://www.wellnessresources.com/affiliate.php
Check out the Wikipedia entry for “Dietician” which is a “protected professional title” in the United States.
http://en.wikipedia.org/wiki/Dietitian
Dieticians graduate with a minimum B.Sc. degree from a university and have undergone rotations with a preceptors in clinical areas, before they sit for licensing boards to obtain their professional license.
“Nutritionists” have a variety of educational backgrounds; some attended colleges, some take “college courses” online and some are self-styled “nutritionists” without any “college” credits…similar to a “toothiologist’s” credentials.
@ Jeff:
“One anecdote doesn’t prove DMAA caused anyone’s death. No connection has been established.”
As WLU pointed out, it’s not just one incident. No one is saying a connection has “been established” but few would disagree that there is sufficient circumstantial evidence of a connection to warrant concern, which is why objective third parties like the military are taking action.
“The FDA cites reasons 2 and 3 in its warning letters about DMAA. This makes the issue one of enforcement, not regulation. Why is the agency taking so long to act?”
I don’t know but I imagine it has something to do with lack of resources. Citing reasons 2 and 3 doesn’t mean there is no evidence of 1. It makes sense that the FDA would try to get DMAA off the market by citing the reasons for which it has the strongest case. In fact, according to the Times story, many of the companies who received warning letters have already removed DMAA from their products. USPlabs and the FDA are apparently in negotiations, although still disagreeing, about whether DMAA must be removed. If the FDA can get products off the market in this manner it is a whole lot cheaper than confiscating them and fighting the issue in court.
So..the conflict of interest between Big Pharma, the FDA and the advice and regulation of drugs (which, let’s remember, must be proven safe and effective in clinical trials for initial use, and to make any claims for off-label use, there must be further clinical trials) – that’s a horror story. But the owner of a company that sells supplements, who gives advice on supplements, who is a world-renowned researcher on leptin, who sells leptin-related products (products which are not proven safe or effective, have no clinical trials, and who are free to make essentially any claim as long as it’s with a nod and a wink) – that’s fine. That’s perfectly acceptable. You can trust him.
Can you explain the distinction to me?
“It’s not a MLM company” is a little like arguing “sure, Pol Pot killed millions of his own citizens – but he wasn’t Hitler“. Talk about damned with faint praise.
The ANH appears to be a health freedom advocacy organization (i.e. the freedom to be bilked out of money for ineffective drug-pretenders) that seems offended at the idea of science-based standards.
Note their comparison:
It sure sounds sciencey (“medical nutrition therapy”, a rather meaningless term since food isn’t medicine) but the “integrative” part suggests they are unscientific practitioners dedicated to overselling supplements. Dietitians meanwhile, appear to practice with a scientific basis and focus on food rather than vitamins. The claim also references doctors, nurses and acupuncturists in the same breath, which is absurd. There’s appeals to “monopoly” (more health freedom rhetoric) but essentially no reference to science. Their recommended reading is quite interesting. I see numerous books that appear to be polemics against GMO, “health freedom”, a pile of books about corruption within medicine, a book by Gary Null (GARY NULL!!!), a nonsense book about how anxiety are caused by toxins and cranialsacral alignment, a book about the failure of the FDA published by “Life Extension Magazine”, and some other wonderful choices.
They oppose vaccination, lie about GMO foods, lie about the FDA’s role, have a lovely dichotomy regarding health sustainability (because our choices really are as simple as trees versus stumps), invokes M-theory (quantum woo!) to draw a distinction between “natural” molecules and “unnatural” molecules, support chelation and according to their “accomplishments“, were leaders in the effort to create the NCCAM.
I was going to suggest we go easy, that there might be a distinction between UK and US definitions of dietitian and nutritionist, but in this case Dara O’Briain seems to be quite correct – these guys are toothiologists. Jeff, you are not supporting your case by invoking this group.
Actually, there hasn’t been just “the one single incident” with Jack3d. There was also the death of Claire Squires, the British marathon runner, in 2012:
http://www.guardian.co.uk/uk/2013/jan/30/claire-squires-runner-dmaa-fatal
The article at Guardian.UK also cites the death of a man in Australia.
Drugs may have benefits that are substantial and life-saving, like antibiotics, for instance, and the risks balance against these. Supplements, however, are taken for vague and frivolous reasons, like enhancing athletic performance or increasing muscle mass. So the burden of proof for safety must be ironclad. If you’re taking a product basically for bragging rights at the pub, or to look better at the beach, there really shouldn’t be any risk at all.
What are the “benefits” of supplements, really? I mean, other than for the bottom line of the people who sell them.
“FDA WARNING: Safety and effectiveness unknown. Use at your own risk.”
Oh, that would be so good! And given what I just read about in this article, it seems not only necessary but properly truthful.
We’ve got the same (or very similar) issues in Australia, with very few effective Therapeutic Drugs Administration restrictions on supplements or alternative therapies.
Iris,
Did you watch the first segment of the first episode of “The Checkout” on the ABC on Thursday night:
http://m.youtube.com/watch?v=nH8GwjLZ9IE
pharmavixen – You beat me to it.
Sorry Jeff, but a coroner’s inquest trumps “Nuh-uh, prove it!” every time. Recommending, as a rebuttal, anything that includes buzzwords such as “integrative” or “health freedom” merely serves to strengthen Jann’s original point.
@Chris – I see you’ve had another sex change. Can’t say I blame you, the queues are always smaller in the men’s loos!
WilliamLawrenceUtridge:
Wow! Your comments are interesting to read, even if I don’t always agree. The articles about nutrition on the Wellness Resources website are some of the best written and most informative you’ll find anywhere. Take for example, This well-referenced summary of research on the tocotrienol form of vitamin E (I take my tocotrienols every day):
http://www.wellnessresources.com/health/articles/tocotrienols_twenty_years_of_dazzling_cardiovascular_and_cancer_research
I donate money to the Alliance for Natural Health and support most of their positions.
“Well-referenced?” I suppose if your only standard is “has references at all.” I actually took a look through their supposed evidence. There isn’t any. Lots of in vitro theorizing, some animal studies, one teensy (25) human study which only got statistically significant results by excluding subjects. And what was the explanation given for excluding those subjects? They were poor responders! Well, duh, if you selectively throw away the bad results you can make what’s left look good.
What that ACTUALLY shows is that there are some interesting effects in vitro, while what human evidence there is fails to show any benefit. THIS is what’s being claimed as sufficient reason to buy the stuff?
Oh yes, and that one study only looked at one of the claimed benefits.
In all seriousness, if that’s what you consider good enough to hold it up as exemplary, it really shows more than anything that the claims being made are completely unfounded.
Your comments are filled with fallacies you don’t appear to recognize. I get my vitamin E from food, since supplements may kill you. Certainly the NIH’s page on vitamin E, far more science-based and realiable than these nutters, is cautious. That seems far, far more like the “best written and most informative you’ll find anywhere”. Primarily because it doesn’t assume a priori that supplements are harmless and beneficial. Why on earth do people object so strongly to getting their vitamins from food?
That’s horrifying. Why would you support an entity that supports pseudoscience and opposes vaccination? Do you like babies dying of preventable but untreatable diseases like pertussis? Vaccinations shouldn’t be a choice, they should be a medical necessity. Happily I would endorse rooftop vaccination through snipers if it brought rates up to herd immunity levels.
Why would you oppose genetic modification, aside from ignorance?
Why do you think “health freedom” is a good thing, when really it is the “freedom” for companies to lie to their customers, distort results and resist any form of meaningful oversight? Why apply such a double-standard? The startling hypocrisy of CAM supporters on this fact alone never ceases to amaze me – drug companies invest billions of dollars in testing and must demonstrate efficacy resulting in conflicts of interest; supplement manufacturers invest almost no money in safety or efficacy but have no conflict of interest. What an immense double-standard.
I have to agree with Scott, the articles seem less “well referenced” than “cherry-picked” and “confirmation biased”. Are you a genetically high-cholesterol pig? No? Then why would you care about results found in genetically high-cholesterol pigs? People aren’t pigs! Or test tubes! You’re assuming that information generated in a lab, under highly artificial conditions, with highly modified subjects, automatically apply to people. Further, you are assuming that people don’t have compensating mechanisms, biology or biochemical pathways that could render the pathological processes in other animals completely moot. There’s a reason you don’t apply the results for bladder cancer in rats automatically to humans – their urine formation is fundamentally different from ours. There’s a reason animal and bench studies are insufficient for anything but further study – people aren’t high cholesterol pigs, or heavily-inbred mice, or isolated cells floating in a test tube.
I’m an army medic assigned to an infantry unit in Afghanistan. Even out here, there is a panoply of supplements that soldiers either order or have sent to them in bulk. As a result of being the resident medical expert (yikes), I frequently get asked which supplements are most effective. I do my best to warn them that not only am I not qualified to confidently appraise their safety and efficacy, but that the research within the medical community is limited and likely biased, depending on the source of research.
Its strange to me that a command surgeon would oppose their use, but the troops themselves have no training on their harm. Such is how business seems to be conducted here. At least in the infantry, if you aren’t using supplements, the perception is that you aren’t trying to be fit.
Anyway, its an uphill battle. Maybe I should make this article required reading.
“Happily I would endorse rooftop vaccination through snipers if it brought rates up to herd immunity levels.”
Someone forgot to take his meds today.
Nope, I just think that people dying from preventable diseases due to spurious, ill-informed, illogical reasoning is stupid. I’m not sure why CAM supporters are so willing to support parents watching helplessly while their infants slowly strangle to death because of pertussis. Why do you think this is superior to getting vaccinated?
Plus, think of how exciting it would make things. There would be people whose job title was “vaccination sniper”. That’s Dr. McNinja territory!
I’m perfectly fine with people who have genuine objections to getting vaccinated not getting vaccinated (i.e. egg allergies, impaired immunity). I am not fine with ignorant middle-class humanities graduates treating the scientific literature as if it were a garden to be picked over based on taste. I am not fine with people who are unable to take or benefit from vaccines dying because of this. Most objections to vaccination are spurious. Believing vitamins and supplements are a substitute is simply wrong.
But please, focus on the obvious joke in my comment and completely ignore the substantive points because you can’t address them and are unwilling to admit your beliefs have zero scientific foundation. Please. It confirms by beliefs about CAM supporters, and there’s nothing us jumped-up chimps like more than confirmation bias.
@ Jeff: WLU provided you with the “patient” page on Vitamin E available at the NIH ODS (Office of Dietary Supplements). Here’s the “professionals” page on Vitamin E from the NIH-ODS, I support the NIH ODS through my tax dollars and I refuse to support the “nutritionist” who hawks his supplements on the internet.
http://ods.od.nih.gov/factsheets/VitaminE-HealthProfessional/
I’m so underwhelmed with the old pig and mouse studies of short duration that you find as the “be all and end all” of dietetic research.
Now see the extended longitudinal RCT/double blinded studies conducted on tens of thousands of humans that are heavily referenced on the NIH-ODS website.
See also, the inability to accurately detect severe Vitamin E deficiencies, which are exceeding rare deficiencies, as long as people eat a balance healthy diet.
(Watch for the anecdote) I participated in an early double blinded placebo controlled trial of Lipitor, chosen because I have familiar hypercholesterolemia and my total cholesterol blood level always approached 400 mg/dL.
When the study was unblinded, my total cholesterol blood level was measured at 180 mg/dL…and has remained at that level for the past 20 years…so obviously I received Lipitor during the trial and the generic Atorvastin that I take every day has kept my total blood cholesterol WNL.
elburto:
Blockquote fail! Well, what I have to say starts with the winking smiley!
Jeff -
Aaand there we have it folks! The ableism cherry on top of the sCAM fail-cake.
sCAM enthusiasts always trip themselves up eventually, and the veneer of ~mah health freedumbs~ cracks wide open, and reveals a fetid, stinking core of anti-science, vaccine-denial, and blockheaded senselessness of the sort that insists that children are better dead from VPDs than “contaminated” by vaccines.
I just read a quote attributed to Neil deGrasse Tyson in this morning’s newspaper — in an obituary, of all things. It was a favorite of the deceased:
“The good thing about science is that it’s true whether or not you believe in it.”
Appropriate for the current discussion, I thought.
“The good thing about science is that it’s true whether or not you believe in it.”
I agree. The science says DMAA is probably not a legitimate dietary ingredient and doesn’t belong in any dietary supplement. The provisions in DSHEA are quite sufficient to remove this substance from the marketplace. This is the first product since Ephedra to warrant this kind of action from the FDA. The science also shows the vast majority of supplements are quite safe – much safer than drugs, vaccines, or even food. Figures from the FDA, CDC, and the American Association of Poison Control Centers show this quite clearly.
“The science also shows the vast majority of supplements are quite safe”
The science shows that the vast majority of supplements are useless in the vast majority of circumstances.
“The good thing about science is that it’s true whether or not you believe in it.”
Provided what is “true” is what the evidence tells us is true, otherwise the same can be said for objects of faith.
While I agree, I will ask – how do you know? Supplements aren’t tested or monitored in anything close to a meaningful way. You should write your congressperson to advocate for better controls over and monitoring of supplements instead of wasting your time here.
Not really, the burden of proof is on the FDA to indicate harms. How does it do this when there is no systematic monitoring? Well, as in this case, people die. Actually, this case isn’t enough – more people have to die. Because supplements are assumed to be safe and effective, not tested, an absurd double-standard you don’t seem to see. If supplements are as effective as you assert, testing should show this easily (as well as any adverse health effects or impact on secondary markers). But you want to maintain your double-standard, wasting money or wasting lives. The FDA doesn’t have resources or the mandate to actively monitor the vast, nigh-endless number of combined and permuted supplements and compounds released every year.
How do you know? Do you monitor the adverse effects of supplements in your spare time? If there were a small, base-rate increase in deaths due to supplements (such as apparently occurs for vitamin E), it would require extensive monitoring.
Well, if “science” does so, since “science” is a public exercise, you should be able to provide references to support your assertions. Please, provide the sources that show that DMAA is both safe and effective. And has been stated here many times – drugs must be proven safe and effective. Drugs are accompanied by a list of side effects, but also a list of main effects that demonstrate you’re getting something for those risks. There’s even risk:benefit calculations made showing nigh-exactly what your chances of dying are versus your chances of living longer.
Safer than vaccines my ass. Vaccines prevent deadly diseases, and the risks are incredibly minimal. Vaccines are so safe it can be difficult to tell if serious side effects are real or illusory. Not to mention safety and effectiveness testing informs you of the substantive risks and what to look for. How do you know what to look for in supplements with no safety testing? You don’t.
If supplements have a biological effect beyond just food, they act as drugs and should be monitored and controlled as such. Why you insist a double-standard, I don’t understand. Actually I do – your personal biases and logical fallacies prevent you from seeing you have a double-standard, and like so many humans you are resistant to admitting you’re wrong.
Please link to the section of their websites where they show the specific monitoring of DMAA.
“Not really, the burden of proof is on the FDA to indicate harms. How does it do this when there is no systematic monitoring?”
Did you read my earlier posts? The FDA can remove DMAA from the marketplace for any of three reasons:
1. It was determined DMAA actually caused serious adverse reactions.
2. The agency decided DMAA is not a legitimate dietary ingredient and therefore not a legal supplement.
3. The agency determines no New Dietary Ingredient application has been filed, with safety data included. This would make any product containing DMAA adulterated (and illegal).
DMAA is a fairly new supplement ingredient. It was not grandfathered in when DSHEA passed in 1994. By law an application for a New Dietary Ingredient application must be filed with the FDA; this must include data showing DMAA can be taken safely under normal use. Since no NDI application has been filed, DMAA is considered adulterated and therefore illegal.
The FDA has sent several warning letters citing reasons 2 and 3. Firms ignoring the warning letters are subject to criminal prosecution with possible fines and jail time. The agency does not have to prove DMAA has caused harm to get it off the market.
There certainly is systematic monitoring of supplement adverse events. Since 2007 the supplement industry has been subject to mandatory reporting of serious AERs. The FDA posts these figures online. The numbers include serious adverse events reported by supplement companies plus reports of all adverse events, both serious and non-serious, submitted by consumers and healthcare professionals:
http://www.accessdata.fda.gov/FDATrack/track?program=cfsan&id=CFSAN-OFDCER-Number-of-mandatory-adverse-event-reports-from-dietary-supplement-industry-entered-into-CAERS&fy=2010
The supplement figures can be compared to those for prescription drugs:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434
Naturally-occurring molecules (supplements) have a far superior safety profile compared to synthetic lab-created molecules (drugs). This is one reason supplements and drugs should not be regulated in the same way.
“If supplements have a biological effect beyond just food, they act as drugs and should be monitored and controlled as such.”
Supplements are safer than food. Data for foodborn illness is posted at the website of the Centers for Disease Control: “CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.”
What if there was the same exposure to supplements as there is to food? We don’t know how many people take supplements precisely, other than extrapolating indirectly from sales. I know I have bought supplements and they have sat in my cupboard until they passed their “best before” date.
But we know everybody eats.
The risk versus benefit still isn’t established here. If we don’t eat, we die. But we don’t need supplements. The whole “wellness” industry is there to convince healthy people that mere health isn’t good enough – we also need “wellness,” and for that we must take supplements.
FWIW, I subscribe to a Health Canada service that sends me advisories, warnings, and recalls. Since 2000, when their website started tracking these, there have been over a thousand recalls of natural products, including supplements, for various reasons, such as contamination with bacteria or heavy metal, finding undeclared DMAA (banned in Canada), and finding all sorts of undeclared prescription medications, including antibiotics, sildenafil (Viagra), diuretics, sibutramine (a weight-loss drug), antihypertensives, etc.
But with tens of thousands of untested supplements on the marketplace, how can the FDA possibly monitor them all? This is one ingredient, removing it leaves thousands more for consumers to waste their money and risk their health on.
But at least for this ingredient, I hope you are advocating your congressperson to pressure the FDA to remove DMAA from the market – without more input and voter pressure, how does the FDA know which ingredient out of thousands to take action on? And if you want to actually address the problem rather than one symptom, you should also advocate for better regulation of supplements and more resources for the FDA. But you won’t, because of your double-standard, drugs are bad, supplements good (even when they kill people through sudden cardiac arrest).
As opposed to all the other thousands of ingredients released unmonitored, unregulated, untested, with no verification of purity, potency and certainly no safety or efficacy. Again, you are focusing on the symptom, not the problem.
The supplement figures can absolutely not be compared to prescription drugs, for a variety of reasons – monitoring is far less systematic, there is no expert role or monitoring from doctors like there are with drugs, there is no process to recognize standard adverse effects that allows easier record keeping, there is essentially no incentive to monitor, there is no biochemical testing or evaluation to guess at what the adverse effects might be, there are no proxy measures that can be monitored, and I’m sure more reasons can be thought of rather easily. Supplements have nothing close to the monitoring of drugs, and also have absolutely nothing comparable in either safety or efficacy. If supplements don’t work, they are a waste of money. If they have a significant biological effect, they act like drugs and are likely to have side effects. Either way, you are taking a risk – hopefully one solely to your wallet.
Bitter almond is natural. How does its safety profile compare to a vaccine? How does mandrake root? Do you consider that natural? How about safe? What about the venom of an Inland Taipan snake? Perfectly natural – how safe is it compared to AZT? What about a fava bean? Is that natural? If someone with G6PD deficiency eats enough of them, they die.
Your assertion that “natural” is safer than “laboratory” is nonsense, it is a product of indoctrination and fallacy, not fact. All substances should be evaluated on a case-by-case basis for both safety and efficacy. Why are you so fond of putting money into Big Supplement’s bottles?
How many people take supplements? Of those, how many are poisoned by them each year? All humans consume food, the same can not be said of supplements, and again, there is nothing comparable in terms of monitoring. You should contact your congressperson to get a fraction of the supplement industries billions of dollars per year to go into safety and effectiveness testing so citizens are no longer putting their health at risk or their throwing their money away on worthless pills that are redundant to food.
pharmavixen:
In his recent SBM post, Who Takes Supplements and Why, Scott Gavura used figures from The National Health and Nutrition Examination Survey (NHANES): just over half the US population (about 157 million people) uses dietary supplements.
The drug-based model of American healthcare doesn’t admit to a therapeutic benefit from any dietary supplement. All supplements are supposedly worthless. But what if certain nutrient deficiencies are more prevalent than many doctors think? Consider the essential mineral zinc, as just one example:
1. http://www.sciencedaily.com/releases/2012/10/121001141003.htm
2. http://knowledgeofhealth.com/modern-day-zinc-deficiency-epidemic/
And the references you offer are a press release for a paper on elderly mice (which is actually here) and a Gish gallop from vitamin salesman Bill Sardi?
Here are some rational thoughts from a real doctor on supplements in general and Bill Sardi in specific. His agenda is solely to sell his brand of supplements. Notice in the comments at the botoom Sardi refuses to answer if he has any science credentials or degrees and lashes out with hostility when confronted.
“Can You Trust Bill Sardi?”
http://mdprevent.blogspot.ca/2012/10/can-bill-sardi-be-trusted.html
He’s just another Mercola or Mike Adams with lots of products to sell.
Update as of March 21, 2013
Bill Sardi or someone working on his behalf sent me two copies of his book, The New Turth About Vitamins & Minerals. On the cover of the book, he displays Purity’s Perfect Multi, the multivitamin he sells. The entire book is dedicated to persuading the reader that if you want a quality multivitamin, only he sells it. In fact, in the back of the book, Sardi includes a survey of multivitamins where he grades the major brands out of 100 points. Not surprisingly, his product gets a 96, with the next closest product is graded 68 out of 100, with the numbers dropping fast from there.
Out of curiosity, I started reading the book, but had to stop when I realized that although he occasionally quoted some reasonable studies, many were studies done in animals, which hold little relevance to humans. The book was the most self-serving book I have ever tried to read. After a few pages of copious notes, I had enough.
Again I caution, beware of people telling you how great are the supplements they are trying to sell you.
Fair enough. Still, it’s an estimate at best in comparison with the absolutely certain knowledge that everybody eats. (Other than the tiny handful who subsist on total parenteral nutrition who I mention in case you do in your next post
Straw man, and not even true. For decades we’ve been promoting calcium supplements for people at risk of osteoporosis, iron supplements for people with iron deficiency anemia, B12 for pernicious anemia, and folate for pregnant women and those trying to conceive, thiamine to prevent Wernicke’s encephalopathy in the treatment of alcohol withdrawal. Promoters of hyervitamin therapy cite the well-documented effects of niacin on lowering cholesterol levels, but we tend to give statins instead not because we hate vitamins, but because statins are safer and have fewer side effects.
If there really were benefits to supplementation as purported by altmed practitioners, Big Pharma wouldn’t suppress that knowledge. Big Pharma would write it across the sky, and make billions. We’ve already seen it already – when there was that hoopla five or six years ago about the Vitamin D deficiency from which we all supposedly suffer, resulting in mental illness, multiple sclerosis, and cancer, we couldn’t keep vitamin D on the shelves. In the city where I live, people were obsessively hysterically phoning every pharmacy looking for elusive stock.
Just a few examples off the top of my head.
Minor correction: Wernicke’s is not part of AWS but rather results from chronic substitution of EtOH calories for solid food.
Marc Stephens Is Insane: I readily concede that an actual doctor’s opinion would carry more weight than mine. But you don’t deal with the substance of Sardi’s article – you only attack him personally.
I merely supplied a link to a website. I paraphrased what the MD who owns the blog said, and stated Sardi is in business to sell his stuff, like Mercola and Adams. How is that “attacking him personally”?
Oddly, neither do you.
THe point is, Sardi, Mercola, Adams et. al. blog about all these supplements and vitamins “we all need” that they just so happen to sell. In my world that means there’s no objectivity; it’s merely advertising. Do you believe Big Macs look as good in real life as on TV commercials? People and companies never lie or bend the truth their products, do they?
Here’s a parallel: if the CEO or Merck or Pfizer had a blog touting his/her company’s medications, you’d scream it’s all conflict of interest, it’s merely marketing, they’re shills, they only want to sell their products, etc. But when a vitamin peddler does the same thing, it’s fair and objective reporting. I see.
Should have written “People and companies never lie or bend the truth to sell their products, do they?”
Probably worth mentioning that, outside of people potentially suffering from osteoporosis, calcium supplements may be doing more harm than good.
That’s nonsense. Evidence-based health care admits there is therepeutic benefit in cases of deficiency, though last I heard there was no such thing as a “DMAA deficiency”. For other claims, evidence-based healthcare requires evidence – precisely what supplement manufacturers are reluctant to provide or pursue because it would add to their overhead and possibly detract from their ever-so-lucrative sales of evidence-free supplements. Also, the health care provided Americans, such as it is, is strongly preventive – vaccines prevent infectious diseases, nutritional fortification prevents deficiency of those rare vitamins not readily available or of special note, dietary recommendations are aimed to support healthy weight and healthy lives. Supplement promoters and CAM supporters like to pretend that health care is not preventive, when really what they want is to sell (or in your case, buy) supplements without restriction. I could claim that supplement manufacturers want to kill helpless babies, but I don’t, because that’s not what they want. Supplement manufacturers just want to make as high a profit as they possibly can without restriction or oversight by the government, or any bad press for the deaths or disability their supplements may cause. Gosh, it’s almost like they’re a company, not some sort of magical firehose of sunshine and rainbows. Certainly Sardi seems quite willing to spin doctor to keep selling his products.
Further, merely because patients don’t follow their doctor’s recommendations to maintain a healthy weight, eat unprocessed foods for most meals and exercise doesn’t mean American health care is drug-based. It means a lot of patients’ corpulence is hamburger-based.
Two points:
1) As MSII notes, you’re linking to the website of someone who sells supplements. Do you think perhaps he might not be the best place to go for neutral information on dietary supplements? Would you ask the president of Pfizer how great his or her latest pharmaceutical creation was and expect an honest answer? Why the double-standard? Why is Bill Sardi, who sells supplements, a neutral source of unbiased information, but the NIH, FDA, CDC and other agencies that don’t sell supplements are somehow villains?
2) Why are you advocating for supplements in this regard? Wouldn’t it be better for people to increase their intakes of lean beef, beans, whole grains, cereals, lean cheeses, chick peas and the like rather than risk losing their sense of smell due to high-dose zinc supplements? It’s bizarre to me that CAM supporters like yourself are so averse to drugs and the like, but also seem averse to getting your nutrients from food. Isn’t that more natural?
As a final point, MSII doesn’t attack Sardi personally – he points out that Sardi has a financial conflict of interest regarding health advice. He also pointed out that humans are not elderly mice, thus illustrating that we perhaps should not treat research on mice as if it applied immediately and universally to humans. Again, there is a double-standard: Big Pharma can’t be trusted because they make billions from selling drugs, but Little Supplement can, because…they make millions selling vitamins? And you would be kicking and screaming of AstraZeneca released a new drug on the basis of rat results, but lab studies on rodents are adequate to recommend zinc supplements (despite the risk of “nausea, vomiting, loss of appetite, abdominal cramps, diarrhea, and headaches…low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins…significant increase in hospitalizations for genitourinary causes, raising the possibility that chronically high intakes of zinc adversely affect some aspects of urinary physiology” and loss of smell). That seems like base hypocrisy.
Jeff, why do you hold such a stringent double-standard? Do you sell supplements for a living?
Yeah, conflict of interest accusations suck.
The bright side of knowing all this news about badly manufactured supplements is that it’s out in the open, and we know the FDA is doing its job of hunting down dietary supplement manufacturers who do not comply with cGMPs. Warning letters have been issued and if these manufacturers still do not comply, they will be forced to close down. This hopefully sends a sharp message to other dietary supplement manufacturers that they better buck up if they want to remain in business. Supplement business owners, like me, have turned to dietary supplement manufacturers who have a proven track record for producing reliable supplements and are regularly audited by reputable third-parties, like the NSF, to ensure they’re properly adhering to GMP guidelines.
[...] . [These] include healing practices using food; food extracts; dietary supplements [as defined in DSHEA] including vitamins, herbs, minerals, and enzymes; nutrients; homeopathic remedies and [...]
[...] done properly, this report could be at least a PR disaster for CAM providers. (Or not. Government reports about problems with dietary supplements do not seem to have tempered the public’s [...]
[...] discussed in a previous post on the subject, both USPlabs and GNC maintain Jack3d (pronounced “jacked”) is safe when [...]