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.'"
Why not give the FDA full control? (Score:0, Insightful)
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?
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:Question (Score:5, Insightful)
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.
Comment removed (Score:2, Insightful)
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.
Re:Not Homeopathic (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.
I find it so strange... (Score:1, Insightful)
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)
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)
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.
Re:Homeopathy is hogwash... (Score:2, Insightful)
Well, there's always dehydration. I think they cure that one pretty nicely :)
Why is this tagged 'medicine'? (Score:3, Insightful)
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.
Re:It's not really homeopathic (Score:2, 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.
Re:There is more to it than meets the eye (Score:3, Insightful)
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'.
Re:Why not give the FDA full control? (Score:2, Insightful)
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...
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.
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.
Re:There is more to it than meets the eye (Score:1, Insightful)
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? :-)
Re:It's not really homeopathic (Score:4, Insightful)
Re:70% of taste = 100% Myth. (Score:3, Insightful)
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.
Re:Pull it off the market (Score:3, Insightful)
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.
Comment removed (Score:5, Insightful)
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.
Comment removed (Score:3, Insightful)
Re:Eh? Homeopathic? (Score:3, Insightful)
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).
Re:It's not really homeopathic (Score:2, Insightful)
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.
Re:It's not really homeopathic (Score:3, Insightful)
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.
Re:It's not really homeopathic (Score:3, Insightful)
The plural of "anecdote" is not "data". By the same standards, there are "widely reported verified stories" of bigfoot.
Re:Political Motivation (Score:3, Insightful)
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?