Homeopathic label let Zicam avoid regulation

[trotsky]

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.

...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.

...

Active homeopathic ingredients are typically diluted down to 1 part per million or less, but some are present in much higher concentrations. The active ingredient in Zicam is 2 parts per 100.

More...

Unlike claims that have appeared in other threads, homeopathic medicine is not "regulated" in the same way that actual working medicines are. This is a good article explaining some of the differences.

[ayeshahaqqiqa]

1. And yet some remedies require a doctor's prescription

and cannot be sold over the counter. Herpes Zoster is an example. I cannot understand the position of the FDA on homeopathic remedies. On one hand, they say they are so diluted that none of the original ingredient is left--and on the other, they say that certain remedies, even in high dilutions, must be regulated.

FYI, most over the counter remedies are, indeed, in a dilution of 1:10. These are remedies marked "x". remedies marked "c" are diluted 1:100. These are considered low potency remedies--the more potent remedies are in higher dilution. Like any medicine, homeopathic remedies work for some folks and not for others. Personally, for me, they work--but then I use them at the recommendation of my homeopathic physician. Helped enormously when I tore a ligament in my foot recently.

[trotsky]

3. There is no set guideline, even among homeopaths...

as to how much something needs to be diluted to be "ready." When stuff is diluted to 1 in a million or 1 in a trillion trillion (more typical of the "potent" homeopathic products), it IS just water and isn't likely to harm anyone. However, as noted in the article, the zinc compound in Zicam was only diluted to 2 parts per 100. That's enough to still be present in the final product.

Plus there's the problem of contamination, without strict guidelines for manufacture. Bottom line is, homeopathic medicines are NOT nearly as tightly regulated as actual medicines.

[ayeshahaqqiqa]

4. My point is there is no reason why they can't be

If the FDA already regulates the prescribing of certain remedies, they can regulate the production, too--at least of the X and C dosages.

[elleng]

2. The company

that manufactures the Zicam nasal spray now at the center of a Food and Drug Administration warning says it had received 800 reports of loss of smell, but didn't report it to the FDA.

The Wall Street Journal reports that in a conference call on Thursday, Matrixx Initiatives Inc. acting president and chief operating officer William Hemelt said he followed the advice of his legal counsel and didn't share the complaints with the FDA. He added that the complaints pertained to people taking the product before they actually got a cold.

http://www.wthitv.com/dpp/healthy_living/general_health/health_dpgo_zicam_800_complaints_lwf_061909_2553192

[Celebration]

6. Is that "off label" use?

Or was it recommended that people take it before they got a cold?

I am wondering if the people affected were taking it more often, or in a different way than the label stated.

[elleng]

7. Who knows?

Don't know that it matters. If it damages olfactory system, would probably happen whenever. Probably no evidence on all the harmed people; certainly haven't been trials to unearth facts.

[Celebration]

9. Well, it would matter

In a court of law, for instance. Just because x might help with colds, that doesn't mean that 2x should be taken before getting the cold.

[elleng]

12. I don't know that anyone's arguing that it does NOT help with colds.

In a trial, what would be useful evidence would depend on what the trial is about, that what is the 'cause of action.'

The problem is caused, I believe, because zinc damages the olfactory system, and there's so much zinc in the stuff that it frequently causes damage. The amount of zinc is out of bounds to be homeopathic. If it's NOT damaging, it wouldn't matter when it was used.

[trotsky]

8. Advertising for Zicam made it quite clear...

that it was to be taken at the "first sign" of a cold. A dry or itchy throat could be the first sign of a cold, or it could just be a sign of low humidity. Could you blame someone for taking their Zicam when they first experience an inconclusive symptom?

[Celebration]

11. no, but they should know after about one dose

whether it is a cold or not.

Were people's sense of smell affected by just one dose of the stuff?

[elleng]

13. Some were.

.

[SidDithers]

10. They also paid $12 million to settle 340 lawsuits...

pertaining to people losing their sense of smell after using Zicam back in 2006.

http://www.washingtonpost.com/wp-dyn/content/article/2006/01/30/AR2006013001240.html

Sid

[elleng]

14. Yes.

They've been aware of allegations for some time.

[SidDithers]

5. The multi-billion dollar nutriceuticals industry...

should be regulated and monitored just like the pharmaceutical industry. All nutriceutical products should have to prove efficacy and safety in controlled double-blind experiments before being licensed for sale.

Sid

[Celebration]

15. So, that includes "head and shoulders" shampoo?

I can't wait to pay close to a hundred bucks to get rid of dandruff, like many new prescription drugs cost.

[SidDithers]

16. Sure, why not? ...

If the product is making a claim to alleviate a medical condition, I'd want to be sure that a) it works, and b) it's safe.

Or are you comfortable taking the word of the company selling you the product that it works, is safe, and contains what it says?

Sid

[Celebration]

17. Are you comfortable

With the prices and/or lack of availability of products like "Head and Shoulders" and Selsun Blue?

[SidDithers]

18. You forgot to answer my question...

Here, let me re-ask it for you:

Are you comfortable taking the word of the company selling you the product that it works, is safe, and contains what it says?

Last time I checked, Head and Shoulders was ~$7.00 / bottle, and was available just about everywhere. I don't see why that has to change just because they have to confirm their products' contents, efficacy and safety.

Sid

[Celebration]

19. I'm VERY happy

With my being able to pick and choose whether to trust a particular company's claims on safety and efficacy.

Uh, that FDA testing you are wanting--hundreds and hundreds of millions of dollars. Someone's gotta pay, and you can bet it won't be the stockholders.

[trotsky]

20. Is every alt-medder a libertarian?

Or just the ones on DU? :shrug: