AP IMPACT: Zicam Not Alone in Side Effect Reports.

[elleng]

The unsettling little secret of Zicam Cold Remedy finally spilled out this week. Though widely sold for years as a drug for colds, it was never tested by federal regulators for safety like other drugs. And that was perfectly legal -- until scores of consumers lost their sense of smell. One little word on Zicam's label explains all this: ''homeopathic.''

Zicam and hundreds of other homeopathic remedies -- highly diluted drugs made from natural ingredients -- are legally sold as treatments with explicit claims of medical benefit. Yet they don't require federal checks for safety, effectiveness or even the right ingredients.

They're somewhat similar to dietary supplements, which use many of the same natural ingredients and also aren't federally tested for safety or benefit.

Many scientists view homeopathic remedies as modern snake oil -- ineffective but mostly harmless because the drugs in them are present in such tiny amounts.

But an Associated Press analysis of the Food and Drug Administration's side effect reports found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide. . .

In 1938, Congress passed a law granting homeopathic remedies the same legal status as regular pharmaceuticals. The law's principal author was Sen. Royal Copeland of New York, a trained homeopath. ''He did it in such a sneaky way that nobody really noticed or paid attention,'' says medical author Natalie Robins.

And that law has remained in force ever since.

http://nytimes.com/aponline/2009/06/17/health/AP-US-MED-Unproven-Remedies-Homeopathy.html

[Buzz Clik]

1. "Complaints ranged from vomiting to attempted suicide. . ." Same effect as reading the Free Republic

:shrug:

[get the red out]

2. Great, now the supplement police

I guess the supplement police will come in with guns blazing after the Zicam thing.

[Ian David]

4. Obama's comin' to take yer spells and potions! n/t

[get the red out]

6. Spells and potions?

Sorry, I don't live in Harry Potter's world.

I also don't appreciate food police, supplement police, belief police, sex police............

Have a problem with freedom? Guess so!

[Ian David]

8. Have a problem with reality?

Homeopathy is not naturopathy.

Homeopathy is MAGIC.

Period.

It's a magic potion created by casting a magic spell upon a substance.

Period.

Of course, people should be free to be ignorant and stupid.

It's how Natural Selection works.

[get the red out]

10. Oh, you have a big problem with freedom

That's what I am addressing here. I never even used a single term you are going off on in my post, yet I get a lecture on things I never expressed a view point on. You are touchy!

You seem more interested in lecturing people and attempting to humiliate them. That stuff should have been left back in 7th grade. One thing is that you are piling a lot of assumptions on someone else for simply calling for freedom to choose; which indicates you are only for freedoms that you approve of, same stance as the religious right but different issues. I imagine you laid in wait for anyone who dared even post a one line response to this particular thread.

[Ian David]

14. People have the freedom to choose. Duh.

Stop putting words in my mouth.

Your magic won't work on me.

[conscious evolution]

51. Quit wasting your time

Let natural selection take care of idiots like him.

[varkam]

66. +About a Million

:rofl:

Thanks for that

[trotsky]

12. Suppose, just for the moment,

that Zicam REALLY DOES CAUSE LOSS OF SMELL. Seriously. Suppose that people truly have been injured (for life) with this product.

Is it really fair to call the FDA "the supplement police" when they step in to stop the damage?

[elleng]

19. Thanks, trotsky.

My daughter has lost her sense of smell and taste, and will be examined at U Penn shortly. I know that I'll learn something thereby; not sure about others.

[trotsky]

20. I'm very sorry for your daughter.

Loss of smell & taste doesn't seem like it would be as debilitating as losing sight or hearing, until you stop to think about it: you can't smell smoke if a fire is starting, or something has shorted out. You can't smell food to see if it's bad. Your life is literally more at risk without being able to smell. Hopefully your daughter's can be reversed!

[elleng]

22. Thanks; I surely hope it can be reversed.

Have been thinking of her lost ability to TASTE! She enjoys cooking, and is just developing those skills. Now that this is in the news, I've thought of the hazards as well.

[Name removed]

32. Deleted message

Message removed by moderator. Click here to review the message board rules.

[elleng]

67. HI! Thought you might be interested, esp. last line of first post::

http://www.lawyersandsettlements.com/blog/week-adjourned-61909.html

[Ian David]

3. Article is wrong. The drugs in homeopathy aren't present AT ALL.

They're diluted past the point of any statistical likelihood that you're getting even a single molecule of what's listed in the ingredients.

What they're selling is the MAGIC "vibrational memory" of something that they admit is no longer physically present in their product.

The problem with Zicam is likely in their "inert" ingredients-- the preservatives or bacteria-contaminated water (like what killed people in Australia).

See:

homeopathy

"...for the purposes of popular discourse, it is not necessary for homeopaths to prove their case. It is merely necessary for them to create walls of obfuscation, and superficially plausible technical documents that support their case, in order to keep the dream alive in the imaginations of both the media and their defenders." --Ben Goldacre

If homeopathy works, then obviously the less you use it, the stronger it gets. So the best way to apply homeopathy is to not use it at all. --Phil Plait


Classical homeopathy originated in the 19th century with Samuel Christian Friedrich Hahnemann (1755-1843) as an alternative to the standard medical practices of the day, such as phlebotomy or bloodletting. Opening veins to bleed patients, force disease out of the body, and restore the humors to a proper balance was a popular medical practice until the late19th century (Williams 2000: 265). Hahnemann rejected the notion that disease should be treated by letting out the offensive matter causing the illness. In this, he was right. On the other hand, he argued that disease should be treated by helping the vital force restore the body to harmony and balance. In this, he was wrong. He rejected other common medical practices of his day such as purgatives and emetics "with opium and mercury-based calomel" (ibid.: 145). He was right to do so. Hahnemann's alternative medicine was more humane and less likely to cause harm than many of the conventional practices of his day.

Scientific medicine was developing in Hahnemann's time but homeopathy would not be part of that development. Scientific medicine is essentially materialistic. It is based on such disciplines as anatomy, physiology, and chemistry. While Hahnemann's methods involve empirical observation, his theory of disease and cure is essentially non-empirical and involves the appeal to metaphysical entities and processes.

Hahnemann put forth his ideas of disease and treatment in The Organon of Homeopathic Medicine (1810) and Theory of Chronic Diseases (1821). The term 'homeopathy' is derived from two Greek words: homeo (similar) and pathos (suffering). Hahnemann meant to contrast his method with the convention of his day of trying to balance "humors" by treating a disorder with its opposite (allos). He referred to conventional practice as allopathy. Even though modern scientific medicine bears no resemblance to the theory of balancing humors or treating disease with its opposite, modern homeopaths and other advocates of "alternative" medicine misleadingly refer to today's science-trained physicians as allopaths (Jarvis 1994).

Classical homeopathy is generally defined as a system of medical treatment based on the use of minute quantities of remedies that in larger doses produce effects similar to those of the disease being treated. Hahnemann believed that very small doses of a medication could have very powerful healing effects because their potency could be affected by vigorous and methodical shaking (succussion). Hahnemann referred to this alleged increase in potency by vigorous shaking as dynamization. Hahnemann thought succussion could release "immaterial and spiritual powers," thereby making substances more active. "Tapping on a leather pad or the heel of the hand was alleged to double the dilution" (ibid.).

Dynamization was for Hahnemann a process of releasing an energy that he regarded as essentially immaterial and spiritual. As time went on he became more and more impressed with the power of the technique he had discovered and he issued dire warnings about the perils of dynamizing medicines too much. This might have serious or even fatal consequences, and he advised homeopaths not to carry medicines about in their waistcoat pockets lest they inadvertently make them too powerful. Eventually he even claimed that there was no need for patients to swallow the medicines at all; it was enough if they merely smelt them. (Campbell)

More:
http://www.skepdic.com/homeo.html

[elleng]

5. You assume:

The problem with Zicam is likely in their "inert" ingredients-- the preservatives or bacteria-contaminated water (like what killed people in Australia).

More likely, imo, that zicam took advantage of available 'homeopathy' label, but did it wrong.


Check this '07 ABC tv report:

http://www.zicam-cold-eeze-lawyers.com/video.asp

[Ian David]

7. Considering that "homeopathic" means an ingredient that is not there...

... then either:

1) They put the actual ingredient in it anyway

or

2) the actual physical stuff in it (non-homeopathic) is the problem

[elleng]

9. It appears to be that

zinc is the problem, and it should not be used in such manner. Its been known since 1938 to cause anosmia.

"Homeopathic" does not mean an ingredient that is not there.

'What are homeopathic drugs?

A. They are highly diluted drugs made from natural ingredients and sold with explicit claims of medical benefit. They are based on a principle unverified by mainstream science: that substances that create certain symptoms in healthy people are effective in treating the disease that causes the same symptoms.'

http://nytimes.com/aponline/2009/06/17/health/AP-US-MED-Unproven-Remedies-Homeopathy-QA.html

[Ian David]

15. THAT article is wrong. That is NOT what homeopathic reads.

I posted an article that explains it.

And there are others, straight from the mouths of the quacks themselves.

[Why Syzygy]

38. Some confusion.

When you say it "does not mean an ingredient that is not there", well yes and no. There are no discernable remnants of the original item used to prepare the remedy. IOW, they do not show any ACTIVE ingredients in lab tests. It is based on an *energetic* model. This is why skeptics scoff.

There is much more to it than "dilution". The NYT is NOT an authority on homeopathic preparations.
This site is:

Homeopathic medicines involve giving patients preparations that are so dilute that they frequently contain none of the original substance.

The manufacture of homeopathic medicine involves two major underlying principles: dilution and succussion. The homeopath dilutes in two main ways – decimal or D (mother tincture diluted 10 times), and centesimal or C (mother tincture diluted 100 times). For example, this means that D15 is the original mother tincture diluted one in 10, 15 times. Between each dilution a period of at least 10 seconds of active agitation of the medication occurs. This active agitation, or succussion, appears to be an essential part of the manufacture of homeopathic medicines.

In allopathic medicine, when prescribing a drug, we often give large doses and tend to work on the principle that the bigger the dose the greater the therapeutic effect. Homeopathic prescribing adopts the opposing view: the smaller the drug dose, the more potent its effect.

http://www.complemed.co.uk/homeopathy/homeopathy2.htm
emphasis added

[trotsky]

11. Yeah, I was confused at first too.

But as it turns out, Zicam does have zinc compounds in significant quantities. All the other stuff is the homeopathic diluted-to-nonexistence standard.

[Celebration]

13. There is such a thing as placebo side effects as well

Don't people report all kinds of side effects for all kinds of things? These media outlets seem to be a bit desperate, and obviously don't know the definition of homeopathy.

There may have been reports of loss of smell because the people using this were obviously having trouble with colds, and because apparently a lot of people were buying the product. What I am wondering is if the science truly supports the loss of smell being a result of using the product?

I'm with the person who thinks a careful look at short sales in the company stock is in order.

[trotsky]

16. Oh, the person who signed up just yesterday...

and whose sole contribution to DU so far has been to throw some FUD around on this one issue?

[Celebration]

17. eh, I'd love to see the short sales

Wouldn't you?

[trotsky]

21. Is there even evidence that they happened?

And what if it's employees/executives of the company, who may have been tipped off early?

My gosh, if this situation were slightly different and had been Merck, you'd be screaming at the FDA for not acting sooner.

[elleng]

23. This has been going on for years!

Who could have known when the 'big' news would be heard?

[Celebration]

49. uh, insiders at the FDA, and anyone they chose to tell n/t

[trotsky]

50. Well, and I tipped everyone off 2 and a half years ago.

http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=222&topic_id=12491

Better blame me.

[Celebration]

52. for insider trading

It is the TIMING that is important.

[trotsky]

53. Ah yes, the timing of knowing something that was already known a few years ago.

Very important.

[Celebration]

54. no the timing of the FDA decision n/t

[trotsky]

55. Sure, to announce something that was known years ago.

Keep trying if you want.

[Celebration]

56. Matrixx slides 68% after FDA warning on Zicam

Sorry, but there was a lot of money to be made with this announcement

http://www.fiercepharma.com/story/matrixx-plummets-68-after-fda-warning-zicam/2009-06-16

Scottsdale, AZ-based Matrixx Initiatives suffered a 68 percent drop in share price Tuesday after federal regulators warned consumers to discontinue use of cold products manufactured by the company. In a release, the FDA said that three of the company's over-the-counter products--Zicam Cold Remedy Nasal Gel, Gel Swabs and Kids Size swabs--could cause "long-lasting or permanent" loss of smell. The agency said it has received over 130 such reports from consumers since 1999 and Matrixx is holding another 800 reports, Deborah M. Autor, head of the FDA's Office of Compliance, told reporters in a conference call today.

[trotsky]

57. That's the price you pay for making a product that was known YEARS AGO...

to rob people of their sense of smell.

You wouldn't shed any tears or feel badly for Merck, why do you look for excuses with these poison-pushers?

[elleng]

59. Good work, trotsky!

.

[Celebration]

60. Wow, WHAT MISUNDERSTANDING

I could care less what the stock price is. Don't you all know the first thing about people making money by shorting stocks???? The potential for making money is HUGE in a case like this. The drop was 68%!! It doesn't matter if the stock price is deserved or not, or if taking it off the market is deserved or not. The potential for insiders to profit from a decision like this is OVERWHELMING. If someone bought a put option on this stock right before this decision they could have made off like bandits. That is the whole point!! I am not saying that insider information was used, but it should be routinely investigated in cases like this, with a stock with such low capitalization.

The potential for insider profit is MUCH less for a company like MERCK because the capitalization is much larger, and the stock price doesn't vary as much, no matter what the news.

This is Econ 101. Get educated!

[elleng]

62. 'Get educated' assumes that people don't know these facts.

Maybe others should recognise that many are concerned about the essential facts presented by this unfortunate occurrence.

Maybe YOU're bemoaning that YOU weren't able to jump on this bandwagon? NOT an insider?

[Celebration]

64. since you all knew so much

You should have shorted the stock yourselves!! Personally I had never heard of this product or this company.

"Get educated" means try to understand the basics of the way stock manipulation works, and the potential for profit, before posting things that make zero sense, and are not responsive to the concern.

[elleng]

65. Right, try to understand.

MY point, of course, is that tho there was public info about zicam's potential for harm as early as 2004, the information was not sufficiently widespread to keep us from USING IT.

IF I KNEW SO MUCH, I would probably NOT have shorted it; I would have warned friends and family against using it. Got it?

[Celebration]

61. what excuses?

I'm not making excuses for anyone. When a regulatory decision is made that drops a stock price by 68%, the SEC should routinely investigate the short sales in the stock, because the potential for gain is humongous. Merck has nothing to with this. Because it is larger, its price doesn't vary as much with news.

I could care less about this company or product. But the stock price drop holds the potential for huge windfalls for anyone that might have had knowledge about the decision ahead of time. Hopefully there were no shenanigans, but it should be looked at as a matter of course, and this applies to ANY regulatory decision that dramatically affects the price of a stock, whether it is the FDA, EPA or whatever.

[elleng]

63. Then write to the SEC about it.

I think we've seen enough.

[trotsky]

69. I'm just laughing here.

Don't mind me. People are being handicapped for life, and you're more worried about someone short-selling the stock of the company that made the poison. Merck has everything to do with this, because if this exact same situation occurred with one of their products you'd be livid - not at anyone who made money with a Merck stock price drop (and yes, its stock takes some big hits), but at Merck and those evul scientist types.

[Celebration]

25. I have to admit this

I do consider that hundreds of thousands of death due to heart problems from Vioxx to be a tad bit more problematic than this.

Actually, I feel that any major regulatory action by any agency, that affects the stock price of a company, should be investigated for possible stock manipulation, just as a matter of course.

[elleng]

18. There is no 'science' on loss of smell being result of using product,

as manufacturer never so tested (not required) and neither does govt. That will happen down the road, if at all, after the hundreds of victims of the 'homeopathic loophole' have their days in courts and/or on the Hill. Zinc, on the other hand, has been known to cause anosmia since the 1930s. There is abundant 'science' here. http://george-eby-research.com/anosmia/jafek-zicam-anosmia.pdf

'Homeopathy is a form of alternative medicine that treats patients with heavily diluted preparations that are thought to cause effects similar to the symptoms presented, first expounded by German physician Samuel Hahnemann in 1796. Homeopathic remedies are prepared by serial dilution with shaking by forceful striking ("succussing") after each step under the assumption that this increases the effect of the treatment; this process is referred to as "potentization". Dilution often continues until none of the original substance remains.<1>' http://en.wikipedia.org/wiki/Homeopathy

Media has not picked up on hundreds of complaints about Zicam use > loss of sense of smell, but has covered local stories since '04. http://www.thedenverchannel.com/print/2825169/detail.html

[Celebration]

24. all kinds of things are getting conflated here

It would seem to me that this should fall into another category besides "homeopathy." I would have thought it would have fallen into the 1994 act. But I guess they just wanted the "homeopathy" category, which seems inappropriate.

Most homeopathic remedies are just water or tiny pieces of sugar with energetic "imprints" on them.

[elleng]

26. However it happened, 'they' wanted it and got it.

I suspect that after this, the 'homeopathy' category will disappear.

[Why Syzygy]

39. We certainly hope not.

The first hospitals in the USA were homeopathic hospitals. The AMA has been trying to shut down homeopathy ever since they gained the upper hand. I will fight tooth and nail and know plenty of others who will too. I would be a HUGE loss of freedom.

[semillama]

27. The media is often guilty of conflating "homeopathy" with all alternative remedies

Of course, the manufacturers of said remedies often do nothing to disabuse the media of that, and often take the mantle up themselves simply because "homeopathy = all alternative medicine" in the minds of a large part of the public.

[Why Syzygy]

28. Was it the zinc?

This sounds like a witch burning being set in motion.

[LaurenG]

30. It was the zinc.

:hi:

[LaurenG]

29. Zicam is not a homeopathic remedy

It's a zinc nasal gel for colds and there's not a cold virus in it that would make it homeopathic. :eyes: (not to you elleng but the article)

[trotsky]

31. Yup, the term is misused CONSTANTLY.

Doesn't help when the media and even products themselves confuse the issue.

[Why Syzygy]

33. Thank you!

Somone who knows! It has ONE ingredient (IIRC) which is *PREPARED* using homepathic methods. That does not make it a homeopathic remedy!

This really steams me :grr:

[elleng]

34. Thanks, LaurenG.

Zicam calls itself homeopathic; therein lies the rub!

I think its a 'serious' issue relating to regulation, or the company's desire to NOT be regulated, and I suspect that it will change.

[Why Syzygy]

37. The regulation issue

has nothing to do with "the company's desire to NOT be regulated..." This is an industry wide standard.
I suppose you want doctors to be the only ones who can prescribe vitamins, herbs and minerals?
There ARE certain homeopathic remedies that are only obtainable by certified prescribers. For example, the one made from the TB bacillus cannot be purchased by just anyone.

Your's are the only anti-alternative posts I can read on this thread. I've got everyone else with that opinion on ignore.

I don't mean to be rude. Though I'm sure I am probably being so. I think you might want to do a bit more research about alternative health care and treatments before you "suspect" things will change and/or blame it on "the company" OR homeopathy.

I'm sorry your daughter has suffered. I knew a man who lost his sense of smell in Viet Nam. I can't imagine.

[elleng]

40. Understand, Why Syzygy, and please don't 'suppose' what I want.

Zicam should NOT have been excluded from FDA examination just because it called itself 'homeopathic.' I think a system which allows this sort of 'sham' is defective.

I am NOT ANTI-ALTERNATIVE medicine; family members have made careers studying, educating and providing such. I am an attorney and a parent. I DO blame the company, as it appears to me (rather uneducated in this area) as seeing some benefit for itself in the 'homeopathic' label, when what it has provided is NOT homeopathic.

The system should recognize that there are certain minerals and herbs that can cause 'dramatic' effects, and the public should not be subjected to such effects unknowingly. (Zinc has been known to cause anosmia since the 1930s.)

[Why Syzygy]

41. So you ARE

arguing for regulation on zinc (for example).
I think a system which allows this sort of 'sham' is defective.

Who do you think is going to do that regulation? I can tell that this is unfamiliar territory for you. But I must defend homeopathy and OTHER natural treatments with ferocity because this is a slippery slope. I understand you and your loved one had a bad experience. Evidently zinc should not be used in nasal passages. I haven't researched this particular reaction, and am unaware if oral zinc has the same potential?

Of course the company thought "homeopathic" would enhance the marketability. But as things stand now in this country and many others, marching in the band for "regulation" is asking for a death sentence for your freedom to make health choices.

... public should not be subjected to such effects unknowingly is part of the FREEDOM we celebrate in this country. Can you not see that? Can you not think of ANY OTHER way that your loved one could have been spared other than taking down the entire alternative health choice? Google? Anything else?

[elleng]

42. I am a retired Federal regulator;

worked for the interstate commerce commission, regulated railroads (and buses and trucks.) 'Competition' was a major issue. I know something about how the system works.

Freedom to lose sense of smell because company wants to sell damaging stuff is NOT PART OF THE FREEDOM I CELEBRATE. I don't know about distinction between oral and nasal zinc, either.

FDA should do the regulating. Unfortunately it hasn't been doing a good job, so people like you are so concerned. It shouldn't be this way. and NO, GOogle can't do it; if it could, it would have, google and the media, that is, as this zicam/zinc issue has been 'out there' since '04.

[Why Syzygy]

43. Yet

buses and rail cars and trucks are still involved in accidents. I don't think you understand how alternative health care works.
And in my POV, your concept of freedom is lacking as well.

You are mistaken if you believe the FDA would do this right. Your attitude is very dangerous to the alternative health care field and those of us who benefit from it. You won't be able to protect everyone no matter what. The FDA fails over and over. You might as well demand the FDA be perfect, along with the entire universe, so no one ever suffers any degree of harm. That is quite an unrealistic expectation. Meanwhile, guess I'll see you at the witch burning. You'll be in the audience. I'm the one on the pile of wood.

You say Google couldn't have done it. But, someone could have. If someone had warned you, would you have listened? Or would you have gone on believing that you know best even though others have more experience? If the information was there, it was discoverable.

[elleng]

44. 'Discoverable'

You have children?

Government is nothing like perfect; often, not good.

Markets? Self-interest of corporations?

SORRY if you're the 'witch.' Nothing I can do about that.

[Why Syzygy]

45. Ellen..

Perhaps consumers will bring a class action law suit against the company. If so, you have a case.
The company won't notify you. The FDA won't notify you. SOMEONE will have to take the intiative and use some kind of discovery skills to determine that. Personally, I would use Google for starters. This is the exact same method used by consumers who are horribly damaged by products regulated by the FDA.

Yes, I have a son. He flies a fighter jet for the USAF. Something happens to him, not a damn thing to be done about it.
He is idealistic enough to believe he is fighting the bad guys for us.

[elleng]

46. Sure have used google to discover that there have been suits.

But did I or my daughter google for 'hazardous cold remedies' 2 years ago? No, though we'd have found Zicam at google if we'd looked for law suits.

[Why Syzygy]

47. "Zicam" would be the appropriate search term to begin with.

I do not put any drug into my body (make a major purchase, try a new whazit, join a club, cast a vote, determine with certainty where I stand on a matter) until I have read both pros and cons. Two sides are always available. Then it's my decision and my responsibility. That is, as long as we still have a modicum of freedom left.

[trotsky]

48. Whoa.

marching in the band for "regulation" is asking for a death sentence for your freedom to make health choices

Speaking of the marching band, I had no idea you were becoming a libertarian. So you think that any company that isn't part of "big pharma" can simply be trusted to always make products that are safe and contain the ingredients they claim? Really?

[mzmolly]

35. Stating the obvious perhaps, but one needs to be cautious before taking any pill/potion.

Just because something is deemed "natural" doesn't mean it's without issue.

[mzmolly]

36. Zicam is voluntarilly withdrawing it's product.

http://www.zicam.com/messagetoconsumers

Though colds can cause a loss of smell, so I'm not entirely convinced that the Zicam is the culprit. That said, I will not use this product until questions are answered.

[McCamy Taylor]

58. I have heard of manufacturers making non-dilute versions of homeopathic remedies and then selling

them--even though dilution is key to the treatment method. Is this still a problem?

[elleng]

68. May be.

http://www.lawyersandsettlements.com/blog/week-adjourned-61909.html