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Comments: 452 +- Science: FDA Says Homeopathic Cure Can Cause Loss of Smell on Wednesday June 17 2009, @08:53PM
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by
samzenpus
on Wednesday June 17 2009, @08:53PM
from the make-sure-to-keep-that-poultice-wet dept.
from the make-sure-to-keep-that-poultice-wet dept.
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Hugh Pickens writes "The FDA has advised consumers to stop using Matrixx Initiatives' Zicam Cold Remedy nasal gel marketed over-the-counter as a cold remedy because it is associated with the loss of sense of smell (anosmia) that may be long-lasting or permanent. The FDA says about 130 consumers have reported a loss of smell after using the homeopathic cure containing zinc, an ingredient scientists say may damage nerves in the nose needed for smell and health officials say they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. 'Loss of the sense of smell is potentially life-threatening and may be permanent,' said Dr. Charles Lee. 'People without the sense of smell may not be able to detect life-dangerous situations, such as gas leaks or something burning in the house.' The FDA said the remedy was never formally approved because it is part of a small group of remedies known as homeopathic products that are not required to undergo federal review before launching. The global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists. Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says it 'will seek a meeting with the FDA to vigorously defend its scientific data, developed during more than 10 years of experience with the products, demonstrating their safety.'"
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It's not really homeopathic (Score:5, Informative)
if it actually does anything at all.
Re:It's not really homeopathic (Score:5, Funny)
While Zicam also makes zinc-containing oral cold remedies, these are not subject to this warning because the development of anosmia appears to be related to the intranasal application of zinc.
Don't these guys know ANYTHING about homeopathic medicines? The strongest ones don't have any of the 'active ingredient' in them at all, you just take sugar pills and think happy thoughts at them until the sun shines out your ass.
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Homeophobic (Score:5, Funny)
Don't these guys know ANYTHING about homeopathic medicines?
Clearly not - they must be homeophobes.
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Re:It's not really homeopathic (Score:5, Interesting)
the interesting thing is that the placebo effect (which you are basically describing) is a very well documented medical fact. in some studies the placebo is actually more effective than the drug being tested, and its not because the drug sucks or that people are faking it. there is a huge misconception and stigma surrounding placebos. MDs prescribe them regularly. they _WORK_ . sure, its basically fooling your brain, but whats wrong with that? if you have a neuralgia or pain or dysfunction and somebody gives you a pill and the condition improves, what does it matter what the pill is made of? placebos should be preferred as they dont have side effects.
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Re:It's not really homeopathic (Score:5, Insightful)
placebos should be preferred as they dont have side effects.
I'm pretty sure this is incorrect. Granted, they're not very harmful, but you could easily experience things like dry mouth, headaches, muscle aches, etc. Remember, your body is reacting as though it received medicine. If someone gives you a placebo and tells you it's a cold remedy, you will probably experience the same side effects you experience with Sudafed.
The prescribing doctor is the cause of the side effects: "Be sure to take these pills with lots of water and maybe a cracker or two, they're really powerful and give some people a bit of nausea."
It's the sales job that makes placebos work, and part of convincing people that it's effective is to add that "powerful" tag. And nobody would believe a perfect pill with no side effects exists, or we'd all be taking them every day.
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Re:It's not really homeopathic (Score:5, Informative)
True homeopathy is the alleged "science" of diluting a substance with water until there is nothing left but water. Only the "memory" of the water having contained the stuff remains. (look up dr.Emoto for more wacky antics surrounding the memory of water. Emoto by the way has a real doctorate but not in a field relevant to his research.)
Many alternative medicines are promoted as homeopathic when they are nothing of the sort.
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Re:It's not really homeopathic (Score:5, Insightful)
Not only that but I remember reading a study on the effect years ago(maybe someone can find a link? My Search Fu does suck) where they gave those in pain morphine for several days and then either gave them a placebo with JUST water, or one with water and a morphine blocker. Now since the morphine was already out of their system the morphine blocker should have had NO effect at all, yet those that were given the placebo without a morphine blocker experienced a reducing of pain while those given the morphine blocker experienced an INCREASE in pain.
They tried these experiments with several other drugs and the results were the same. We really don't know WTF is going on when it comes to the human brain, not really. IMHO the placebo effect shows that we can never know with 100% certainty what a drug is going to do, becase the human brain can skew the outcome one way or another. That is why research on the brain and the electro-chemical reactions is so important. We really need to understand how the entire machine works to design effective drugs.
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Not necessarily... (Score:5, Informative)
According to the warning letter [fda.gov] the solution contains "an active ingredient measured in homeopathic strength--Zincum Gluconicum 2X".
2X equals to 1:100 solution - which may be quite a significant dosage of the "active ingredient", depending on its nature. [wikipedia.org]
Incidentally, this is not the first time this particular maker of this particular homeopathic drug has been a cause of this particular health concern. [wikipedia.org]
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Re:It's not really homeopathic (Score:4, Insightful)
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Re:There is more to it than meets the eye (Score:5, Insightful)
The plural of anecdote is not data.
Even if you for some reason choose to ignore the science known as chemistry, data acquired in a good manner shows that homeopathic "medicines" have no more effect than a placebo. It most definitely does not work.
Being a "skeptic" achieves not being fooled into taking placebos instead of proper drugs, which can save your life in many cases.
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Re:"Proper" drugs aren't that great either. (Score:5, Interesting)
Only rhetorically. If taking "proper" drugs kills you one in 10,000 times and not taking them kills you 9 times out of 10, then it is not a "toss up", meaning 50%-50%. Is there a one-word term for "blindness to orders of magnitude"? Most ideologues seem to suffer from it.
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Re:There is more to it than meets the eye (Score:5, Insightful)
If you want to convince us that homeopathic medicines work, than by all means, put one of them through a rigorous, controlled clinical trial. (Not one anecdotal bit that may or may not be true and if it is may or may not be coincidental.) Tell one group they're getting the homeopathic "medicine" and give that to them. Tell the other group that's what they're getting and give them a placebo. Compare the results. That's how accurate results are obtained about the effectiveness of an actual drug against the placebo effect.
If you find significantly better results in the side that took the "medicine" than in those who took the placebo, and those results prove to be repeatable, you may have yourself a case. But until someone is confident enough in the method to submit it to rigorous, controlled testing, rather than "It worked this time! Really! Don't be so closed minded!", it's just quackery preying on the gullible.
When proponents of something are quick to tout its benefits and quick to ridicule its critics, but even quicker to duck rigorous testing that would show for sure if it really works or not, I become very closed minded very quickly. I've never taken Zicam, so apparently I can still smell bullshit just fine. If you're that confident in it, put it up for FDA approval.
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Re:There is more to it than meets the eye (Score:5, Funny)
I had a cold. I stayed in bed and ate chocolate for a couple of days, and my cold went away. From this I learned that (a) chocolate is a cure for the common cold and (b) having a cold causes you to gain weight.
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Re:It's not really homeopathic (Score:5, Insightful)
Randomized controlled trials is the only way to tell if it "*really* works". Anecdotes are worthless in evaluating (alleged) cures. For every useless substance there is, you *will* find users who "used to be skeptics" but now "swear by them", falsely convinced they "*really* work". Because of post hoc ergo propter hoc, spontaneous remission, false diagnosis, placebo effect, confirmation bias and a slew of other fallacies.
Evangelists like yourself and peers with poorly developed critical thinking skills (ie. most humans) are the exact reason these "cures" are still around - despite having no biological plausibility and negative RCT results against them.
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Works both ways (Score:3, Informative)
Homoeopathic medication consists of almost only inactive ingredients. The so-called active ingredients are typically diluted beyond the point of having any real effect. In this case, that could be an excellent defense for Matrixx.
http://www.youtube.com/watch?v=Xd23gBkhf9A [youtube.com]
Cheers!
Re:Works both ways (Score:4, Informative)
Homoeopathic medication consists of almost only inactive ingredients.
Well the active ingredients can actually have pharmacological effects, whether beneficial or adverse, but like you said the point is that they are often diluted so much that there is not a single molecule of the active ingredient left in the solution. However, there are different dilution ratios used, and some products actually aren't diluted enough for the effects to disappear, which can be dangerous as apparently was the case with this particular "medicine".
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Re: (Score:3, Insightful)
Basically, zicam only calls itself homeopathic (and it may have other "ingredients" diluted to ho
If I hadn't used so much Zicam Cold Remedy.... (Score:5, Funny)
Pull it off the market (Score:5, Insightful)
This product needs to be removed from the market. I'd like to see stricter controls on things like this. Anything that attempts to cure or prevent disease needs to be evaluated and tested by the FDA. All supplements, vitamins, these cold prevention products should all have to shown to be safe and do what they claim BEFORE they can be sold.
Re:Pull it off the market (Score:5, Insightful)
Are you genuinely claiming to be too stupid to tell the difference between a curative and a vice? Here's a hint, on the tobacco label, there's generally a warning saying "Tobacco will kill you". On this zinc "medicine", there's no warning label saying "Warning: will permanently disfigure you", and the manufacturer peddles it as being both safe and effective.
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Not Homeopathic (Score:5, Informative)
The odd bit of this story that no one really seems to be reporting is that this medicine, although sold under the "homeopathic" provisions of FDA regulations (and thereby bypassing the normal approval process), is not a homeopathic medicine as the term is usually used.
If you go read the wikipedia entry on Homeopathy [wikipedia.org], you can see that the way homeopathic medicines are made involves taking a substance and then repeatedly diluting it with water, alcohol or sugar. Most homeopathic medicines are diluted repeatedly until the level of dilution is such that statistically, there is unlikely to even be a single molecule of the original substance remaining. Homeopaths consider higher levels of dilution to be more powerful. They generally believe that the water "remembers" the shape of the original substance.
The Zicam nasal spray is only diluted 100:1 (2X or 1C on homeopathic scales), meaning that it is within the range of normal dilutions used in preparing drugs for delivery, not diluted to a level used in homeopathic remedies. It's being governed by rules meant to only cover placebos, but at that concentration, it's not a placebo. It's a real drug which can have real side effects. If the rules have allowed this drug to come to market legally then those rules have a huge loophole and need to be fixed ASAP. But no one seems to be noting that.
Re: (Score:3, Insightful)
You ninja'd my comment!
Yes, I hope that the FDA acts quickly on redefining 'Homeopathic' as dilutions over a certain level (1ppm perhpas, the chemical equivalents of 3C) before one of these companies actually kills someone directly.
Re:Not Homeopathic (Score:4, Insightful)
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Eh? Homeopathic? (Score:5, Informative)
Homeopathic quackery is infamous and justly ridiculed for the fact that its 'remedies' contain exactly no active ingredients and - unsurprisingly - also have exactly no biological effects. This zinc based stuff is obviously not homeopathic.
Better scent than anything else. (Score:5, Interesting)
I've lost my smell to nasal polyps and chronic sinusitis years ago, it's a little disappointing sometimes but sometimes it's nice not having to smell awful things.
I've heard that when you can't smell you can't taste, which is bullshit. I can't tell the difference between some things but I do very much have a vivid sense of taste still.
And you know that "You lose one sense you gain another" thing? It doesn't work with smell.
i can totally see this happeining (Score:5, Funny)
wife: thats nice dear, Beano?
husband: no, this is better just one sniff and your cured forever
Zicam is not homeopathic. (Score:5, Interesting)
Homeopathic remedies (which I prefer to call homeopathetic...), as others have stated, are diluted until there is a low to zero probability of them containing 1 molecule of substance.
This is stated to be a 1:100 dilution, which is 1% active ingredient: a significant concentration of a proven active (and detremental) ingredient.
There use of homeopathic labels (2X, which means 2 dilutions of 1: 10) was done simply to avoid FDA attention, and they are likely to get into deep trouble because of it.
Here's the meta-analysis (Score:3, Informative)
Cochrane Database Syst Rev. 2000;(2):CD001364.
Update in: Cochrane Database Syst Rev. 2006;(3):CD001364.
Zinc for the common cold. Marshall I.
National Center of Epidemiology and Population Health, Australian National University, Canberra, Australia, 0200. marshali@health.qld.gov.au
OBJECTIVES: Interest in zinc as a treatment for the common cold has grown following the recent publication of several controlled trials. The objective of this review was to assess the effects of zinc lozenges for cold symptoms.
SEARCH STRATEGY: A search was made of the Cochrane Controlled Trials Register, MEDLINE, EMBASE and reference lists of articles. Searches were run to the end of 1997.
SELECTION CRITERIA: Randomised double blind placebo-controlled trials of zinc for acute upper respiratory tract infection or cold.
DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality.
MAIN RESULTS: Seven trials involving 754 cases were included. With the exception of one study, the methodological quality was rated as medium to high. For most outcome measures different summary estimates were used across the studies to describe the duration, incidence and severity of respiratory symptoms. This limited the ability to pool results. Results from two trials (04 - Mossad; 08 - Smith) suggested zinc lozenges reduced the severity and duration of cold symptoms. However, there was significant potential for bias, and further research is required to substantiate these findings. Overall, the results suggest that treatment with zinc lozenges did not reduce the duration of cold symptoms.
REVIEWER'S CONCLUSIONS: Evidence of the effects of zinc lozenges for treating the common cold is inconclusive. Given the potential for treatment to produce side effects, the use of zinc lozenges to treat cold symptoms deserves further study.
(This meta-analysis was actually withdrawn, and I don't know why, maybe to evaluate more recent data.)
I *knew* it! (Score:3, Funny)
It's much safer to stick with homeoerotic cures instead.
Re:I *knew* it! (Score:4, Funny)
Let me guess... they're all suppositories?
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Re:Fucking idiots (Score:5, Informative)
http://www.google.com/products?q=zicam [google.com]
Quick, buy it, pretend that you lost a sense of smell (let me see them prove otherwise) and then wait for a nice settlement check. Just kidding, that would be dishonest.
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The skunk test (Score:3, Interesting)
Lost your sense of smell have you?
Then of course you'd have no problem spending a few hours in a room full of skunks would you.
I kinda think they could devise some test to show that you were faking it.
Food flavor etc. (Score:5, Informative)
Usually my sense of smell does but one thing: annoy me.
I highly doubt that. You just don't realize what your sense of smell is doing for you. For example, about 70% of what you think of as "taste" when you are eating food comes from your sense of smell. Without a sense of smell, your food will taste rather bland and you probably wouldn't be able to appreciate the more subtle flavors (and definitely the aromas) of various foods. Try it yourself. Next time you are stuffed up with a cold, try eating one of your favorite foods and see if it is still as full of flavor as you remember.
While humans don't use pheromones as actively as other animals, the sense of smell still plays a big part in arousal (and in stopping arousal, to be fair). Good smells make sex better. You do want to have better sex, don't you? (insert the "oh wait, this is slashdot" quips here).
And finally, all those things that annoy you about sense of smell are probably also helping to save your life. It lets you know that something is wrong (bad air, bad food, bad place, etc).
So, for a person's overall quality of life, I'd say that the loss of the sense of smell is a pretty big deal. It is not one of the senses I would want to lose. I'd rather lose my ability to hear.
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Re:Food flavor etc. (Score:4, Informative)
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Re:Food flavor etc. (Score:4, Funny)
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Re:70% of taste = 100% Myth. (Score:4, Informative)
Perhaps that is your situation and I believe you, but I doubt my grandfather fills in the gap 50 years later.
I can taste all those things fine, but it is not a memory, since I can easily discern quality in all these things, not just "this tastes like coffee, mmmm memory of coffee smell." I have a full range of likes and dislikes in coffee, bitters, sweets, carmely notes, stale coffee, strong coffee, my work serves starbucks and a better local brew, if someone fills up my cup with the starbucks blend not thinking there is a difference I can immediately tell, I cant smell coffee at all, my grandfather really is a wine connoisseur, he runs large taste testing events, you can't fill in the gap to taste the subtleties of wine, the casks they were aged in, etc.
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Re:Fucking idiots (Score:4, Insightful)
Yes, but ammonia isn't marketed as something you snort or drink. Zicam is indeed marketed as a nasal spray.
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Re:Anosmia? (Score:4, Funny)
"My dog has no nose."
"How does he smell?"
"Awful!"
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Re: (Score:3, Informative)
Anosmic
Doesn't have the simplicity of blind or deaf, I know.
Re: (Score:3, Funny)
Re:Question (Score:5, Insightful)
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Re:Question (Score:4, Funny)
No sense of taste: Zune?
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Re:Zicam is not homeopathic... (Score:5, Informative)
That's odd... Their website appears to be at odds with your reality. [google.com]
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Re:Zicam is not homeopathic... (Score:5, Interesting)
Well, you're right that it's not really homeopathic, but you're wrong about it never being marketed as such. In fact, the word "Homeopathic" appears right on the front of the box, as is plainly visible here [madprofessor.net].
However, the concentration of the active ingredient is around 2%, whereas the concentration in a true homeopathic "cure" would be approximately 0%. Basically, they marketed an unproven drug as homeopathic, when it wasn't, in order to get around FDA regulations.
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Re:Zicam is not homeopathic... (Score:4, Informative)
Zicam Allergy Relief Nasal Gel is an over-the-counter homeopathic nasal gel that provides safe and effective relief from the symptoms of hay fever and other upper respiratory allergies, such as runny nose, sneezing, itchy and watery eyes, nasal congestion, and sinus pressure.
(Emphasis mine). So they themselves definitely describe it as homeopathic.
What made me laugh was this later entry in the Q&A:
Q: Why could it take 1-2 weeks before I notice the effect of Zicam Allergy Relief Nasal Gel?
Zicam Allergy Relief Nasal Gel begins working from the first time you use it. While it is not understood why consistent use over 1-2 weeks is necessary to see results, clinical research on this product indicate that it may take one to two weeks to see a decrease in symptoms. For best results, use Zicam Allergy Relief Nasal Gel up to one week before contact to known causes of your allergies.
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Re: (Score:3, Funny)
Re:Why do people even take pharmacudical drugs? (Score:5, Interesting)
Sure, except when it doesn't, or is faced with a wound or pathogen that the body simply can't handle.
if people expanded their horizons and stopped popping Advils or taking Zicam when they aren't feeling well and taking another root (natural medicine, anyone?), It's guaranteed society would notice a difference
Ah, so you know of a root that is an analgesic, or which has anti-inflammatory properties? That's nice. Can you tell how to provide exactly the right amount of that root, prepared in exactly the right and consistent way, to produce just the anti-inflammatory effect needed without also causing liver or kidney trouble, or provoking an allergic response? Really? So, can you explain to a couple hundred thousand local witch doctors exactly how to predictably prepare, store, and dispense that substance so that anyone traveling can be sure they're getting just what they know will work, no matter where they go? I see, so we need some standards for preparation and dosing, just to be safe? I know, let's call those "pharmaceuticals."
I know precisely how much Ibuprofen will relieve a handful of aches and pains that I can routinely get from certain physical activities. I can find it anywhere, and bank on the results. I'm glad that I don't have to go into an "alternative medicine" shop and get what I hope will be the right sort of powdered root extract from a guy who also promises me that ground up rhinocerous horn will improve my love life.
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Re:Homeopathy is hogwash... (Score:4, Funny)
Fair enough. I will concede that homeopathic products can treat thirst. Also, if applied topically, they can provide temporary relief from dry skin.
-jcr
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Re: (Score:3, Interesting)
Because before the FDA I could grow my own poppies for pain, brew my own ephedra tea for sinus infections and use whatever the earth gave me for whatever I desire. Take chamomile tea. According to you, the FDA (or someone) would have to prove it is safe and effective to be sold, essentially meaning that it would disappear overnight as no one would spend the money to do that. Its a slippery slope from being able to grow and use my own medicine to Equilibrium, where I have to take my government mandated dose
Re:Why not give the FDA full control? (Score:4, Interesting)
I'm trying to think of a downside to making all medications and supplements require FDA approval.
The downside is that the process produces both:
- long delays (during which people suffer and perhaps die) and:
- enormous costs (which keep some safe-and-effective drugs from reaching the market and raise the costs of medications which DO make it through the gauntlet - and must pay for both themselves and their share of the ones that fail).
When the legislation was first proposed it was estimated that if it added six months to the introduction of new medications it was a net loss. Now it takes years and tens of millions of dollars per new drug that starts testing.
One estimate of these costs - in a Wall Street Journal headline - is that the delay required for approving the use of Beta Blockers in the US to prevent secondary heart attacks (after they were approved for that in Europe) resulted in 100,000 deaths.
That was a Wall Street Journal editorial page essay -- which is a completely different thing from the reliable WSJ news stories.
If I recall correctly (can't find it on the WSJ's lame search engine) the author of that essay was a doctor who gave up the practice of medicine to work on Wall Street, and then became an FDA official under the Bush Administration. He has a right to give up medicine for finance, and work for a Republican administration, but it shows the free-market ideology that he's coming from.
Yes, it takes longer to approve drugs, during which the people who would have been helped by those drugs have to do without and in theory might die sooner. (BTW, there are very few "life-saving" drugs these days. Most of those drugs at best extend life by a few months. A drug that extends the life of a lung cancer or colon cancer patient by 3 months is a big deal.)
But when they put drugs on the market without enough testing, as they did when free-market conservatives ruled the FDA, they sold drugs that did more harm than good, like Vioxx and fen-phen.
So less regulation actually killed people rather than saving lives.
If you have a bunch of useful drugs, mixed up with a bunch of harmful drugs, and you can't tell which is which, those drugs can overall do more harm than good. You can't just throw drugs out on the free market and wait to see whether they save more people than they kill.
You can't figure it out from economic theory alone. You have to look at the facts. Before we had regulation, drug companies used to sell useless drugs that would kill people. When the Republicans cut back on regulations, drug companies sold more useless drugs that kill people. Regulation saves more lives than they cost.
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