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Medicine Science

FDA Says Homeopathic Cure Can Cause Loss of Smell 452

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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FDA Says Homeopathic Cure Can Cause Loss of Smell

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  • Repeat (Score:2, Interesting)

    by Foxxxy ( 217437 ) on Wednesday June 17, 2009 @10:05PM (#28368747)

    Since when did Slashdot become CNN's day after repeat? Must be a slow geek week as this isn't the first repeat

    Zicam [cnn.com]

  • by PoiBoy ( 525770 ) <(moc.sgnidlohiop) (ta) (nairb)> on Wednesday June 17, 2009 @10:11PM (#28368799) Homepage
    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.
  • The skunk test (Score:3, Interesting)

    by CanadianRealist ( 1258974 ) on Wednesday June 17, 2009 @10:13PM (#28368813)

    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.

  • by artor3 ( 1344997 ) on Wednesday June 17, 2009 @10:15PM (#28368825)

    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.

  • Re:Fucking idiots (Score:2, Interesting)

    by TinBromide ( 921574 ) on Wednesday June 17, 2009 @10:25PM (#28368891)
    I know someone who was suckered into taking a sip of ammonia when she was a little kid. 40 years later and she still doesn't have a sense of smell. They still sell ammonia, granted I'm talking apples and oranges (cleaning product vs something meant for use INSIDE the human body), but the ratio of puyers/drinkers of ammonia may only be slightly higher than the ratio of buyers of zicam/people who lost their smell. I use it to clean certain kinds of messes (i tend to clean with a chemist's mindset, if it reacts, it is no longer a mess, it is a salt), but on occasion, I lose the sense of smell and get a sore throat for a few hours. Though that tends to happen more so with bleach than ammonia.

    Zicam is everywhere, even if there was a recall, you'd probably have 3-4 cold/flu seasons before you couldn't find it anymore.
  • by Aphoxema ( 1088507 ) * on Wednesday June 17, 2009 @10:32PM (#28368933) Homepage Journal

    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.

  • by robbak ( 775424 ) on Wednesday June 17, 2009 @10:35PM (#28368955) Homepage

    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.

  • by ScentCone ( 795499 ) on Wednesday June 17, 2009 @11:23PM (#28369235)
    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.
  • by Nightspirit ( 846159 ) on Wednesday June 17, 2009 @11:26PM (#28369261)

    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.

  • by MeatBag PussRocket ( 1475317 ) on Wednesday June 17, 2009 @11:27PM (#28369269)

    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.

  • by nbauman ( 624611 ) on Wednesday June 17, 2009 @11:29PM (#28369287) Homepage Journal

    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.

  • by Darkness404 ( 1287218 ) on Wednesday June 17, 2009 @11:58PM (#28369427)

    Even if it takes 10 others?

    10 others that know that it is untested and has no guarantee that it will work? Sure. Now, of course even without the FDA there is still some liability if they didn't properly test it on animals first, but if they knew the risks but still took it, its their problem.

    What if they die 2 hours later?

    ...Of what? Unless you were giving them a toxin, massively overdosing them, or they had an allergic reaction there are few cases that someone would die two hours later. People have allergic reactions to all kinds of "safe" medicines, with some, yes they could die. Both the toxins and overdoses could be charged as fraud.

    Yes, and all people are completely rational actors with perfect information...

    If the information is wrong, sue the manufacturers. There is no reason that a government that protected against fraud and force could not be a modern, free and productive society. If people aren't acting rationally on it, its their problem not society's.

  • by NotSoHeavyD3 ( 1400425 ) on Thursday June 18, 2009 @12:17AM (#28369531)
    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 [blogspot.com] That is weird though, it's a fake "fake drug".
  • by aywwts4 ( 610966 ) on Thursday June 18, 2009 @01:07AM (#28369871)

    "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.

  • by Citizen of Earth ( 569446 ) on Thursday June 18, 2009 @01:49AM (#28370075)

    Not taking "proper" drugs can save your life too. It's a bit of a toss-up.

    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.

  • by Anachragnome ( 1008495 ) on Thursday June 18, 2009 @02:54AM (#28370317)

    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.

  • Memory of Water (Score:1, Interesting)

    by Anonymous Coward on Thursday June 18, 2009 @05:14AM (#28371245)

    Chemistry is not enough. It's 2009 here. Quantum physics might be more appropriate. Anyway...

    # Thermodynamics of extremely diluted aqueous solutions.
    Elia V, Niccoli M.
    Ann N Y Acad Sci. 1999 Jun 30;879:241-8.

    # Permanent physico-chemical properties of extremely diluted aqueous solutions of homeopathic medicines.
    Elia V, Baiano S, Duro I, Napoli E, Niccoli M, Nonatelli L.
    Homeopathy. 2004 Jul;93(3):144-50.

    # The 'Memory of Water': an almost deciphered enigma. Dissipative structures in extremely dilute aqueous solutions.
    Elia V, Napoli E, Germano R.
    Homeopathy. 2007 Jul;96(3):163-9.

Executive ability is deciding quickly and getting somebody else to do the work. -- John G. Pollard