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Medicine Science

FDA Says Homeopathic Cure Can Cause Loss of Smell 452

Posted by samzenpus
from the make-sure-to-keep-that-poultice-wet dept.
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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  • by Anonymous Coward on Wednesday June 17, 2009 @10:01PM (#28368713)

    I'm trying to think of a downside to making all medications and supplements require FDA approval. If everything on the counter had to be certified as both safe and effective, it'd kill the snakeoi-ahem, supplement, industry. But would we really lose out on any potential groundbreaking drugs? Has anyone ever heard of an OTC supplement that went on to revolutionize medicine because it got to market before the big bad government could look too closely at it?

  • by sqrt(2) (786011) on Wednesday June 17, 2009 @10:05PM (#28368751) Journal

    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:Question (Score:5, Insightful)

    by pyrrhonist (701154) on Wednesday June 17, 2009 @10:29PM (#28368915)
    One thing you can be sure of is that a kid with these all problems sure plays a mean pinball.
  • Re:Fucking idiots (Score:4, Insightful)

    by nwf (25607) on Wednesday June 17, 2009 @10:41PM (#28368981)

    Yes, but ammonia isn't marketed as something you snort or drink. Zicam is indeed marketed as a nasal spray.

  • by jcr (53032) <jcr&mac,com> on Wednesday June 17, 2009 @10:42PM (#28368991) Journal

    I'm trying to think of a downside to making all medications and supplements require FDA approval.

    Where to begin?

    If you can't imagine that freedom is a viable option, then have you considered the thousands of people who die every year waiting for the bureaucrats to allow them to use the medicine they need?

    -jcr

  • by geekboy642 (799087) on Wednesday June 17, 2009 @10:42PM (#28368997) Journal

    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.

  • Re:Not Homeopathic (Score:3, Insightful)

    by robbak (775424) on Wednesday June 17, 2009 @10:44PM (#28369007) Homepage

    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.

  • by Anonymous Coward on Wednesday June 17, 2009 @10:51PM (#28369055)
    The same people who are screaming that we need the FDA to regulate this kind of thing are the same ones who doubtlessly bitch about big pharma this and big pharma that.

    What's so odd, you may ask? Obviously these guys don't know the industry as the FDA is the big brother that keeps big pharma in line.

    If you think the pharmaceutical industry is out of hand now wait until you give the FDA power over supplements and herbals. It'll be a fucking slaughter by the largest of pharmaceutical producers with the FDA kicking anyone back in play who doesn't have the money to buy their way into legitimacy. No one with less than a few billion on their side will ever get anything to market without the blessings of the FDA.

    Think it's a joke? Than please shut the fuck up until you learn how the industry works and how the FDA makes it near impossible to get even the least effective drugs to market without putting more money into their pockets than all the Wall Street bonuses over the last decade.
  • Re:Works both ways (Score:3, Insightful)

    by PieSquared (867490) <isosceles2006NO@SPAMgmail.com> on Wednesday June 17, 2009 @11:10PM (#28369173)
    The notation for homeopathic dilution is #X where 1/(10^#) is the percent concentration of the "active" ingredient. Typical strengths of 10X or even 100X are so small that they have no effect. In Ziacam, however, the active ingredient is Zinc, and the dilution is 2X. A 1% solution isn't dilute enough to completely discount effects when you're spraying it into your nose several times a day for several weeks.

    Basically, zicam only calls itself homeopathic (and it may have other "ingredients" diluted to homeopathic amounts), it isn't *actually* homeopathic. Calling yourself homeopathic when you're not is crazy enough that I had to verify this a few years ago...
  • Re:Not Homeopathic (Score:4, Insightful)

    by fusellovirus (1386571) on Wednesday June 17, 2009 @11:15PM (#28369195)
    This is loophole that needs to be filled. a detailed discussion why is here [sciencebasedmedicine.org]
  • by alexhard (778254) <alexhard@@@gmail...com> on Wednesday June 17, 2009 @11:18PM (#28369207) Homepage

    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.

  • by Anonymous Coward on Wednesday June 17, 2009 @11:19PM (#28369213)

    Well, there's always dehydration. I think they cure that one pretty nicely :)

  • by MartinSchou (1360093) on Wednesday June 17, 2009 @11:42PM (#28369353)

    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 [wikipedia.org] and drowning.

  • by dloose (900754) on Wednesday June 17, 2009 @11:44PM (#28369363)

    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.

  • by MrMista_B (891430) on Wednesday June 17, 2009 @11:46PM (#28369371)

    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'.

  • by dloose (900754) on Wednesday June 17, 2009 @11:52PM (#28369399)
    I just can't help being contrarian...

    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.

  • by plover (150551) * on Thursday June 18, 2009 @12:56AM (#28369811) Homepage Journal

    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.

  • by Anonymous Coward on Thursday June 18, 2009 @01:23AM (#28369943)

    Specifically the subject stopped having uneasy sleep, which it had been having for a long time, just by taking a few drops of a bach flower remedy on a regular basis.

    I just did a Google search. Bach Flower remedies [wikipedia.org] are not homeopathic [wikipedia.org]; they contain measurable amounts of flower extracts, plus 27% brandy [bachflower.com] as a preservative. Homeopathic remedies are made by astonishing amounts of dilution [wikipedia.org].

    However, your basic point is not that Bach remedies are homeopathic, but that science is not all that impressed by them (just like science is not all that impressed by homeopathy). So I guess it doesn't matter whether Bach remedies are homeopathic or not.

    Well, don't forget that placebos [wikipedia.org] work too. Now, if you could demonstrate that the Bach remedies work better than placebos, I'd be interested. I'll tell you right now, in my book the Bach remedies are placebos. Placebos with 27% brandy content.

    By the way, how many drops of brandy would it take to make a child sleep more deeply? :-)

  • by BobGarcia (603334) on Thursday June 18, 2009 @01:24AM (#28369949) Homepage Journal
    Homeopathy is the molecular analog to astrology.
  • by OrigamiMarie (1501451) on Thursday June 18, 2009 @01:58AM (#28370119)
    I lost my sense of smell as an infant, and I know that I miss a lot. Most herbs are pretty much bitter leaves to me, lots of spices are mostly a lost cause, and artificial fruit flavors in candy are pointless (I notice the different levels of sweet and tart, that's it). Texture does a lot for me. I have not bothered with alcohol because (a) I am a very grounded sort of person who likes to stay in touch with my senses and mental abilities and (b) it's pretty much just the alcohol flavor, the best stuff would probably just taste like nice fruit juice to me.

    The sense of smell is a funny thing. Apparently people are likely to mentally "fill in the blank" for what they should be smelling when they have lost the sense. It is easy for it to be a phantom sense. You quite likely partially taste the subtleties and subconsciously fill in smells to go with them. But that's only because you know what to fill in. And not all people will do the fill-in job as well as you when the sense of smell leaves them.

    Things you may be filling in (reports of differences between what's described to me and what I get):

    Is citrus zest anything more than bitter and perhaps a little hot? If so, you're filling in the gap.

    Are cucumbers bland? If not, you're filling in the gap.

    Is plain coffee just plain bitter? If not, you're filling in . . .

    Are different candies just variations on sweet and sour? If not, then . . .

    Do herb-infused oils do anything special for you? Is so, then . . .

    I can't think of anything else now, but you get the idea. Smell is very closely linked with memory -- smells easily bring memories to mind and memories easily bring smells to mind.

    That said, there is a lot to be enjoyed without the sense of smell. It's just a narrower field that probably takes some getting used to, and supportive friends and family will help.

  • by sqrt(2) (786011) on Thursday June 18, 2009 @01:59AM (#28370125) Journal

    Uh...we already do it with alcohol and tobacco. Check your beer can, it says you should drive or operate machinery, and your pack of Marlboro 100s warn that they cause lung cancer. I'm saying legalize other drugs and apply this same standard.

  • by hairyfeet (841228) <bassbeast1968 AT gmail DOT com> on Thursday June 18, 2009 @02:25AM (#28370219) Journal

    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.

  • by assert(0) (913801) on Thursday June 18, 2009 @04:12AM (#28370831) Homepage

    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.

  • by jcr (53032) <jcr&mac,com> on Thursday June 18, 2009 @04:46AM (#28371073) Journal

    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

  • by Ihlosi (895663) on Thursday June 18, 2009 @05:13AM (#28371235)
    The thing I don't get is this: why doesn't it count as a "homeopathic remedy" when you drink a glass of normal water?

    Duh, because the uncontrolled mixing disrupted the natural vibration flow and depolarized the energy matrix. That's elementary, really.

    (Funny how similar technobabble and homeobabble are).

  • by mdwh2 (535323) on Thursday June 18, 2009 @06:23AM (#28371575) Journal

    Where do we get these placebos???

    Sure, there are interesting arguments about the use of placebos. But that's no excuse for allowing people to profit by selling water, fraudulently claiming it does something that it does not. Note also that homeopath believers typically claim that it has an effect beyond that of a placebo.

    And yes, if we were just wanting to use placebos, you are right: what does it matter what the pill is made of. There is no need to go through the long winded homeopathic ritual, you could just give them water and tell them you'd done whatever hocus pocus to it.

  • by Ichoran (106539) on Thursday June 18, 2009 @11:33AM (#28374693)

    Morphine works because it mimics natural opioids. It's extremely unlikely that a morphine blocker wouldn't block any natural opioids at all. That's the whole point--morphine and natural opioids are too close to each other in structure.

    So the expectation should be that the morphine blocker *would* cause an effect because it blocks the natural opioids.

  • by c6gunner (950153) on Thursday June 18, 2009 @11:03PM (#28384867)

    Widely reported [what-is-cancer.com], verified stories prove otherwise.

    The plural of "anecdote" is not "data". By the same standards, there are "widely reported verified stories" of bigfoot.

  • by Ihlosi (895663) on Friday June 19, 2009 @09:30AM (#28388835)
    What are the odds the FDA "discovered" this association because Zicam is a big sponsor on the Rush Limbaugh radio show?

    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?

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