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FDA Says Homeopathic Cure Can Cause Loss of Smell
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.'"
Seriously, I get a cold, I can't smell anything either. So really, it seems I'm damned if I do, damned if I don't.
if it actually does anything at all.
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
Cheers!
Atheist: Buddhist in a Prius
If I hadn't used so much Zicam Cold Remedy I would say this smells fishy.
my site of misleading and incorrect information!
It seems to be still on sale though:
http://www.google.com/products?q=zicam
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.
Negative moral value of force outweighs the positive value of good intentions.
Since when did Slashdot become CNN's day after repeat? Must be a slow geek week as this isn't the first repeat
Zicam
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.
If you build it, nerds will come. Soylentnews.org
"My dog has no nose."
"How does he smell?"
"Awful!"
Anosmic
Doesn't have the simplicity of blind or deaf, I know.
That's odd... Their website appears to be at odds with your reality.
This warning only applies to the version of Zicam that you stick in your nose. When I have a cold, I use the lozenges that dissolve in your mouth, and I swear they really do help control the symptoms of a cold.
Sig (appended to the end of comments you post, 120 chars)
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, 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.
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.
That's smelling impaired you insensitive clod.
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.
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.
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.
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.
Rampant carbon sequestration destroyed the Dinosaurs' tropical paradise. I'm here to help repair the damage.
According to the warning letter 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.
Incidentally, this is not the first time this particular maker of this particular homeopathic drug has been a cause of this particular health concern.
Mit der Dummheit kämpfen Götter selbst vergebens
One thing you can be sure of is that a kid with these all problems sure plays a mean pinball.
Show me on the doll where his noodly appendage touched you.
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.
"Most people, I think, don't even know what a rootkit is, so why should they care about it?"
husband: honey, i have a cure for those smelly farts i have
wife: thats nice dear, Beano?
husband: no, this is better just one sniff and your cured forever
Politics is Treachery, Religion is Brainwashing
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.
Prediction for end of Universe #42: Fencepost error in Quantum_bogosort.cpp
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.)
It's much safer to stick with homeoerotic cures instead.
Dear Slashdot: next time you want to mess with the site, add a rich-text editor for comments.
Yes, but ammonia isn't marketed as something you snort or drink. Zicam is indeed marketed as a nasal spray.
I don't know, but it works for me.
Don't these guys know ANYTHING about homeopathic medicines?
Clearly not - they must be homeophobes.
No sense of taste: Zune?
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.
"Empathise with stupidity, and you're halfway to thinking like an idiot." - Iain M. Banks
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.
Infinite time means everything that can happen, will. You being you is absolutely incidental. You do not exist.
Well, there's always dehydration. I think they cure that one pretty nicely :)
The body has phenomenal healing capabilities
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.
Don't disappoint your bird dog. Go to the range.
Fair enough. I will concede that homeopathic products can treat thirst. Also, if applied topically, they can provide temporary relief from dry skin.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
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 every day and nothing else is available.
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.
It's not medicine. If it was medicine it would be labeled as such AND it would have a provable effect.
It's water! How often does that need to be said? The only effect it has is as a placebo. And for those who believe that you can't overdose on homeopathy I have two terms for you: Water poisoning and drowning.
So the kid was cured by sugar-water?
I hope the kid never gets an actual illness, because if that's the way the parents 'take care' of their child, I'd call that 'negligence likely to cause death'.
Or you know, people can and do die because a cure can't be tested fast enough to be 100% certain that it works, however if it cures one life, its worth it.
Even if it takes 10 others?
I mean, if someone was dying of cancer and had only a year to live, took a drug, it worked temporarily and they die 10 years later because of something the drug did, thats still better (no one can live forever).
What if they die 2 hours later?
Plus, just look at the "miracle berry" case, where the FDA was essentially bought by the sugar industry that prevented a potentially useful item to market.
Miracle berries are shit. They make everything taste cloyingly sweet for at least an hour after you eat them.
A free market regulates itself if it is free enough.
Yes, and all people are completely rational actors with perfect information...
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.
To fight the war on terror, stop being afraid.
And it's even in an effective dosage, at least that's what I got from this blog post http://cmpalmer.blogspot.com/2005/04/zicam-homeopathic-cold-remedies.html That is weird though, it's a fake "fake drug".
Did you know 80 to 90% of the moderators on slashdot wouldn't recognize a troll even if one dragged them under a bridge.
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.
"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."
Bullshit. My grandfather and myself both have anosmnia, this lie gets perpetrated as fact time and time again with only the cold "evidence" as backup.
My grandfather is locked in a trunk with a skunk and not noticing smell-less, I am 90% there, I didn't believe him when he said taste was not affected, he is a wine connoisseur. I can't smell most foods, and I was conscious of my gradual loss of smell since I knew he couldn't smell. Everything tastes absolutely 100% A-OK. If we have colds, everything tastes wrong and dull just like it does for everyone else.
Smell is important for many reasons, gas leaks mainly, (my grandfather almost died) 70% of taste is not one of those reasons.
The is almost no research done into anosmnia, so somehow this smell myth has never been challenged. We taste great, I am an excellent cook, and a connoisseur of many items, with an ability to taste subtle flavors most miss, often accurately pinning down variations in ingredients, compared to my smell-full family have unrefined tastebuds and any X is an X, with no variation in quality.
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I've seen a few alternative medicine companies labeling their snake oil as homeopathic for that purpose. In fact, you could say that they're diluting the term.
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.
"Furthermore, since water will have been in contact with millions of different substances throughout its history, critics point out that any glass of water is therefore an extreme dilution of almost any conceivable substance, and so by drinking water one would, according to homeopathic principles, receive treatment for every imaginable condition."
Alchemist: Be Thou For the People
I suspect that the "homeopathic" tag was put on the product to avoid the costs associated with bringing to market a medication that would otherwise have to go through the FDA approval process, a lengthy and costly venture.
To be honest, with the amount of crap sold on TV ads these days, I would be perfectly happy if the FDA put the kibosh on "natural supplements" and homeopathic remedies. Snake-oil salesmen all. As far as my own research can tell me, most of these products do nothing but make money for the people selling them.
If the product actually did something, SAFELY, then these people would be trying to get FDA approval as it would greatly increase their credibility. Even after millions of dollars of profit, the makers of Zicam STILL don't seek FDA approval...because they know it wouldn't make it through the process.
I think it's worthwhile that we have some kind of system in place that stops such dangerous drugs and remedies from reaching the public at all, BEFORE anyone is harmed/defrauded.
Ever heard of the Underwriters' Laboratories?
Personally, I'd prefer to have the safety and efficacy of products I buy vetted by an organization that has something to lose if they're wrong, than by a bureaucracy which will probably see its budget increased if they fuck up.
-jcr
The only title of honor that a tyrant can grant is "Enemy of the State."
and you could do this:http://wings.buffalo.edu/aru/preprohibition.htm.
Check out Bayer's ad for Heroin, or the Cocaine Toothdrops.
Since your claim is that the nerves are damaged, a quick fMRI would prove that your brain is receiving signals from you undamaged nerves.
Tiller's Rule: Never use a word in written form that you've only heard and never read. You will end up looking foolish.
If it contains enough Zinc atoms to be detected (let alone have an effect) it's not diluted nearly enough to really be homeopathic.
Not saying homeopathy isn't a scam, mind, just this once they're being abused by worse scammers.
What are the odds the FDA did not discover this association in the last eight years because Zicam is a big sponsor on the Rush Limbaugh radio show?