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filthy
SFN Die Hard
USA
14408 Posts |
 Posted - 06/17/2009 : 02:08:45
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Maybe.....
But it remains to be seen. The homoeopathy quacks have a lot of influence.
F.D.A. Warns Against Use of Popular Cold Remedy
Published: June 16, 2009
Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.
The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions against drug companies than the Bush administration did.
The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.
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It might also be a good idea to lay a little extra scrutiny on the "big" drug companies as well. I have been reading that they too, keep ineffective and even dangerous products on the market.
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"What luck for rulers that men do not think." -- Adolf Hitler (1889 - 1945)
"If only we could impeach on the basis of criminal stupidity, 90% of the Rethuglicans and half of the Democrats would be thrown out of office." ~~ P.Z. Myres
"The default position of human nature is to punch the other guy in the face and take his stuff." ~~ Dude
Brother Boot Knife of Warm Humanitarianism,
and Crypto-Communist! 
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Dave W.
Info Junkie
USA
26020 Posts |
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filthy
SFN Die Hard
USA
14408 Posts |
Posted - 06/17/2009 : 06:54:44 [Permalink]
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Originally posted by Dave W.
PZ Myers has a Zicam defender in the comments.
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A couple, actually. The problem with PZ's comments is that so many show up so fast that it's impossible to keep track. Thus, I never go into them very deeply.
I found it on Google News @ around 5 AM or so, and don't know if I scooped PZ this time or not.
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"What luck for rulers that men do not think." -- Adolf Hitler (1889 - 1945)
"If only we could impeach on the basis of criminal stupidity, 90% of the Rethuglicans and half of the Democrats would be thrown out of office." ~~ P.Z. Myres
"The default position of human nature is to punch the other guy in the face and take his stuff." ~~ Dude
Brother Boot Knife of Warm Humanitarianism,
and Crypto-Communist!
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BigPapaSmurf
SFN Die Hard
3192 Posts |
Posted - 06/17/2009 : 07:10:36 [Permalink]
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Some great comments there,
"Since it is a fake homeopathic product[not diluted], it may actually work .." ScienceCat
"Almost all metals other than potassium, sodium and calcium have toxic effects on the body." Rev. BigDumbChimp |
"...things I have neither seen nor experienced nor heard tell of from anybody else; things, what is more, that do not in fact exist and could not ever exist at all. So my readers must not believe a word I say." -Lucian on his book True History
"...They accept such things on faith alone, without any evidence. So if a fraudulent and cunning person who knows how to take advantage of a situation comes among them, he can make himself rich in a short time." -Lucian critical of early Christians c.166 AD From his book, De Morte Peregrini |
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BigPapaSmurf
SFN Die Hard
3192 Posts |
Posted - 06/17/2009 : 07:14:31 [Permalink]
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What do you make of this one?
Posted by: JunkScience | June 16, 2009 10:51 PM
I'm warning you. It's a disaster waiting to build: when the scientist-talking-heads start reporting versions of stories without questioning them, without providing explanations of the fallacies, and without even bringing in authoritative scientific voices to knock their claims down, all you do is feed the media frenzy. It's even worse than "he said she said" journalism. That's exactly what This Blogger has done.
I found this site when I googled “Zicam” by “most recent”, obviously not “most relevant”. I am appalled that a blog dedicated to the scientific view would host this blogger. I call for your voluntary removal.
I would hope that a real science view would have pointed out any or all of the following. Real science is evidence and researched based, and hard. Blogging garbage as science-guru is easy and no different from anti-science creationist ragings you claim to warn against.
First, “Homeopathic” is a FDA designation, based on earlier laws grandfathering many drugs including aspirin (which by the way has never been “approved” by the FDA) and grouping them into regulatory, not therapeutic, categories. Zicam's active ingredient and dose fall in this category. Specifically the FDA called out in their warning letter today that this drug was “manufactured and distributed without FDA approval under enforcement policies set out in the FDA's Compliance Policy Guide ...(CPG 7132.15)” [Per FDA] enforcement discretion...”
Zicam has an active pharmaceutical ingredient (Zinc) with both a KNOWN mechanism of action, and peer reviewed journal articles of double blind randomized patient studies showing EFFICACY. (Mr Blogger, I feel I need to remind you that real scientists consider this kind of study as the Gold Standard)
The known mechanism of action is that elemental Zinc interferes with the cold virus attaching via the zinc finger cell wall receptor. Thus blocking viral uptake into the cell.
The efficacy of Zinc has been shown in peer reviewed journal articles. For example this one from the Cleveland Clinic ( http://qjmed.oxfordjournals.org/cgi/content/full/96/1/35 ) OR this one; http://www.jfponline.com/Pages.asp?AID=1464
Anosmia (lost of sensation of smell) is a KNOWN rare side-effect of the cold virus infection. Even rare side-effects in diseases that are common (“common cold”) are thus expected. Given the large number of people with the common cold, and knowing that in America most cold suffers take cold remedies such as Zicam, one would expect a number of victims of anosmia who also have taken Zicam. A scientist, (not this Blogger), might point out that correlation does not prove causation.
The scientific question is: “is there an excess number of anosmia suffers in those patients who took Zicam vs, those cold suffers that did not take Zicam?” (That is called a hypothesis). ( And the answer is there is no evidence for this hypothesis.)
The more relevant question is also: Is the scientific community able to muster a rational inquiry or have the “talking heads” such as this Blogger joined the media frenzy. |
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"...things I have neither seen nor experienced nor heard tell of from anybody else; things, what is more, that do not in fact exist and could not ever exist at all. So my readers must not believe a word I say." -Lucian on his book True History
"...They accept such things on faith alone, without any evidence. So if a fraudulent and cunning person who knows how to take advantage of a situation comes among them, he can make himself rich in a short time." -Lucian critical of early Christians c.166 AD From his book, De Morte Peregrini |
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Dave W.
Info Junkie
USA
26020 Posts |
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Kil
Evil Skeptic
USA
13476 Posts |
Posted - 06/17/2009 : 10:11:00 [Permalink]
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What gets me is there is an active ingredient. Apparently the manufacturer wants to cash in on the word “homeopathic” while not actually being one. (In this case, "homeopathic" is being used as a synonym for “natural” in this cynical piece of marketing. This is a kind of dual quackery because of the homeopathic claim, which to anyone who knows better, means that there is nothing of value in the bottle anyway.) Ironically, if Zicam were really a homeopathic, the stuff wouldn't be causing health problems because of the extreme dilution of whatever was supposed to be the medicine in the product.
To me, this is just another reason to get rid of the Dietary Supplement Health and Education Act of 1994 which makes the marketing of this kind of product possible, even if it's breaking the DSHEA rules by marketing a product without making sure it's safe. Zicam has been on the shelves for many years now, and it took this long for the FDA to catch up to it… |
Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
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Dave W.
Info Junkie
USA
26020 Posts |
Posted - 06/17/2009 : 10:34:28 [Permalink]
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The DSHEA isn't responsible for the fake homeopathic marketing. Homeopathic "drugs" are all approved under the Food and Drug Act of 1934. A homeopath Congressman got that into the bill.
The fake homeopathy was even worse with Loma Lux for psoriasis. The "regular" product has nickel at 3X (1,000-to-1 dilution), while the "prescription strength" version had nickel at 1X (10-to-1 dilution), which is completely backwards from the way homeopathy is supposed to work, with more-effective medications being more and more dilute (to the point where the most-popular homeopathic flu medicine would need only a single duck's liver to make enough tincture to treat everyone, everywhere, until the heat death of the universe - it's made at a whopping 400X). |
- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too. |
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Kil
Evil Skeptic
USA
13476 Posts |
Posted - 06/17/2009 : 10:58:44 [Permalink]
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Originally posted by Dave W.
The DSHEA isn't responsible for the fake homeopathic marketing.
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I didn't say it was. Perhaps I wasn't clear. What I was commenting on is the fact that Zicam wasn't sufficiently tested before marketing. The DSHEA addresses that but leaves it to the manufacturer to comply, which makes it the FDA's problem, after marketing. That's the DSHEA' main weakness.
Obviously, there is a whole homeopathic industry. And if Zicam were really a homeopathic, it wouldn't be in trouble now because there would be nothing in the bottle.
My other comments have to do with the cynical marketing of the product.
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Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
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Dave W.
Info Junkie
USA
26020 Posts |
Posted - 06/17/2009 : 11:13:43 [Permalink]
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Well, no, the DSHEA was targeted at herbs and vitamins - "dietary supplements" - and their marketing. It said nothing about homeopathics, which were "approved" in 1934, and marketable under 1934 rules.
Basically, one brand of snake oil was grandfathered into the original Food and Drug Act, which was passed (in part) in order to eliminate snake oil. |
- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too. |
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Kil
Evil Skeptic
USA
13476 Posts |
Posted - 06/17/2009 : 11:31:40 [Permalink]
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Originally posted by Dave W.
Well, no, the DSHEA was targeted at herbs and vitamins - "dietary supplements" - and their marketing. It said nothing about homeopathics, which were "approved" in 1934, and marketable under 1934 rules.
Basically, one brand of snake oil was grandfathered into the original Food and Drug Act, which was passed (in part) in order to eliminate snake oil.
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Oh, I see.
The FDA says this:
| The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval. |
So Matrixx got Zicam on the shelves because it lied about it being a homeopathic, which is protected by a purposefully placed flaw in the older law.
Well, I'd say that that law need to be revised too.
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Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
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filthy
SFN Die Hard
USA
14408 Posts |
Posted - 06/17/2009 : 15:36:30 [Permalink]
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Update: Upset with the U.S. Food and Drug Administration, Zicam maker Matrixx Initiatives Inc. has withdrawn two of its cold remedy nasal products even though company officials maintain the products are safe.
The FDA said it received more than 130 complaints from consumers saying they have lost their sense of smell after using the products.
Jennifer Warren, a former school teacher who lives in Huntsville, Ala., said she lost her sense of smell after using Zicam to prevent the duration of a cold a few years ago, but had never complained to the FDA or the company because she figured there was no way to prove Zicam caused her anosmia.
She said she doesn't want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even after learning others have had the same experiences.
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"What luck for rulers that men do not think." -- Adolf Hitler (1889 - 1945)
"If only we could impeach on the basis of criminal stupidity, 90% of the Rethuglicans and half of the Democrats would be thrown out of office." ~~ P.Z. Myres
"The default position of human nature is to punch the other guy in the face and take his stuff." ~~ Dude
Brother Boot Knife of Warm Humanitarianism,
and Crypto-Communist!
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Ricky
SFN Die Hard
USA
4907 Posts |
Posted - 06/17/2009 : 17:25:32 [Permalink]
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From JunkScience:
I would hope that a real science view would have pointed out any or all of the following... Anosmia (lost of sensation of smell) is a KNOWN rare side-effect of the cold virus infection. Even rare side-effects in diseases that are common (“common cold”) are thus expected. Given the large number of people with the common cold, and knowing that in America most cold suffers take cold remedies such as Zicam, one would expect a number of victims of anosmia who also have taken Zicam. A scientist, (not this Blogger), might point out that correlation does not prove causation. |
I would imagine that a scientist would actually try to find statistics comparing the percentage of people on Zicam with anosmia, versus the percentage of those not taking it.
When you have a relatively new drug on the market, which is administered through the nose, and you get correlation, this is enough to suspect something is up. Correlation may not prove causation, but it is certainly strong evidence that something is going on.
Dave wrote:
| "JunkScience" is an idiot. He actually says, "trust me, I'm a doctor." |
Agreed, but obviously this doesn't mean everything he says is wrong. I'm actually rather interested in the statistics I mentioned above. He possibly does have a point with the upper respiratory tract infections being the cause of the anosmia.
If I had more time right now, I'd try to dig up those statistics myself, but unfortunately I have to run. |
Why continue? Because we must. Because we have the call. Because it is nobler to fight for rationality without winning than to give up in the face of continued defeats. Because whatever true progress humanity makes is through the rationality of the occasional individual and because any one individual we may win for the cause may do more for humanity than a hundred thousand who hug their superstitions to their breast.
- Isaac Asimov |
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Paying attention at last?
