Zicam and Rush Limbaugh.

[Fuzz]

June 18 (Bloomberg) -- Matrixx Initiatives Inc. said today it didn’t turn over to U.S. regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs.

Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning “a surprise,” during a conference call with analysts.

The FDA found 800 reports of consumer concerns in May during a routine inspection, William Hemelt, acting president and chief operating officer of Matrixx, said today during the call. Hemelt said he was told by lawyers that a 2007 regulation requiring companies to turn over reports of serious side effects didn’t apply to the complaints received by Matrixx. The recall will cost the company $10 million and will increase its product liability costs, he said.

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA said June 16 that it had received 130 reports from doctors and consumers about permanent loss of smell linked to the medicines. FDA spokeswoman Siobhan DeLancey said in a June 16 telephone interview that Matrixx was required to turn over reports of side effects to the FDA according to the 2007 regulation.

The company today withdrew its earnings and sales forecast for 2010.

http://www.bloomberg.com/apps/news?pid=20601087&sid=aABaipe0smcA

BEGIN TRANSCRIPT

RUSH: Jackson, Michigan, Ann, welcome to the EIB Network. Hello.

CALLER: Hi, Rush.

RUSH: Hi.

CALLER: I want to thank you and Zicam for saving my book tour and my life.

RUSH: Saving your book tour and your life, Zicam?

CALLER: Absolutely.

RUSH: How did that happen?

CALLER: Well, I have sarcoidosis, which is the same lung disease that Bernie Mac had when he died. I also am the author of children's books and recently I was on a two-week book tour of elementary schools when I started catching a cold. I took Zicam, which I had never taken in my life, and actually have always thought that you're ads for it were really hooey, you know. I never believed that it would work.

RUSH: Did you send me an e-mail last night?

CALLER: I sure did.

RUSH: Because I read your e-mail and I was going to print it out and bring it in for the next time I had to record a Zicam commercial, and when you used the word hooey I remember reading your e-mail because you thought -- and, by the way, I was profoundly insulted, because here you are, regular listener, telling me you think I'm lying to you about things. And so you thought Zicam was a bunch of hooey.

CALLER: I did. I really did. Until I needed it, and I used it because of my disease and my compromised immune system, I cannot catch a cold. And I go into elementary schools all the time to do presentations for my books, and so I want to say thank you. I want to tell you how wrong I was and how much I appreciate the product. I also have a lot of trouble with public speaking. I cough a lot of because of my disease, and in fact right before I came on air with you, I took Zicam Cough Max, and that works just wonderfully.

RUSH: (laughing) Zicam Cough Max.

CALLER: I did.

RUSH: I hope you took the daytime formula.

CALLER: Absolutely.

RUSH: So it wouldn't make you sleepy.

CALLER: Yeah. Yeah. And I've used it a lot for public speaking.

RUSH: Well, that's just great. I have one question.

CALLER: Uh-oh.

RUSH: No!

CALLER: I'm fearful of your questions.

RUSH: No, no, no. Don't be fearful. You think the product is hooey, you hear me talk about Zicam and what do I say? I say if you think you're catching a cold, use it the minute you think so, you got to catch it early. It may not stop it, but it will certainly slow it down and shorten the duration. Why did you try it if you thought it was hooey?

CALLER: Because I was desperate. I've never been away from home for two weeks, and I had signed a contract to do a two-week book tour of elementary schools. And I happened to hear you 48 hours before I was to leave on my book tour, and your advertising it, and I went to the store, and I thought, you know, this thing probably doesn't work, I'm probably not going to need it, but I took it anyway, and I'm really, really glad that I did. I'd like you to allow me to return the favor. I'd like to send you a signed copy of my children's book Christmas Tree Farm for your nieces and nephews.

RUSH: Wow, that's very nice. If you'll stay on hold, Mr. Snerdley will give you the details on how to do this.

CALLER: Okay, thanks so much, Rush.

RUSH: Ann, thank you very much. What it means is you never did think it was hooey because if you thought Zicam was hooey you would have never even tried it.

CALLER: Well, that's probably true.

RUSH: All right.

CALLER: Thank you so much, Rush.

RUSH: Same here. Appreciate it.

END TRANSCRIPT

http://www.rushlimbaugh.com/home/daily/site_120908/content/01125111.guest.html

[katandmoon]

1. Wonder how much Zicam paid for that.

[SmileyRose]

2. LOL - transparent much? LOL

[underpants]

12. Yeah a caller who just happens to agree with him AND sent him an email

and she got on the show... hmmmm :think:

[SmileyRose]

18. My bet is either his employee or Zicam's posing as a "caller".

[aquart]

3. Zicam gel swabs WORK.

Damn the unpleasant side effect. They knock colds flat out.

I am so BUMMED that I can't use them again.

[vixengrl]

4. And Camels are smooth on your tongue and good to your throat.

It's been a long time since such overt "bill-paying" was worked into radio patter. That's what we call a "professional" in this neck of the woods.

The word "prostitute" is so objectionable nowadays....

[BrklynLiberal]

5. Can one assume that even nitwits like Limpball's regular listeners will be able to see thru

that self-serving piece of crap?

[zbdent]

9. remember ... Rush isn't there to spread the truth ... most of them know he's spreading

the propaganda ... they're hoping he convinces the ignorant ...

[laugle]

6. My husband and I have been using Zicam for 7 years.

I use to get 2-3 colds a year, now it's been 2 years or more since I've had one.

We take it in conjunction with 'Cold eeze' lozenges if we get a sore throat, it's like a miracle cure. We have experienced no side effects.

Both are homeopathic products. From what I know, problems occurred due to over use. I talked with the company a year ago when I first heard these complaints, I was satisfied enough to continue using the product.

The cynical part of me says that the pharmaceutical industry is behind this voluntary recall, since less colds mean less money to them. Think about it, there have been 130 cases that were settled for 12 million dollars. Contrast that with all the new drugs approved by the FDA which turned out to be deadly. Simple logic tells me there's a skunk in the house and it doesn't pass the smell test.

We never over use, 1 dose of Zicam and 1 lozenge does the trick! It's a great product and we will simply use it in the other forms.

[laugle]

7. My husband and I have been using Zicam for 7 years.

I use to get 2-3 colds a year, now it's been 2 years or more since I've had one.

We take it in conjunction with 'Cold eeze' lozenges if we get a sore throat, it's like a miracle cure. We have experienced no side effects.

Both are homeopathic products. From what I know, problems occurred due to over use. I talked with the company a year ago when I first heard these complaints, I was satisfied enough to continue using the product.

The cynical part of me says that the pharmaceutical industry is behind this voluntary recall, since less colds mean less money to them. Think about it, there have been 130 cases that were settled for 12 million dollars. Contrast that with all the new drugs approved by the FDA which turned out to be deadly. Simple logic tells me there's a skunk in the house and it doesn't pass the smell test.

We never over use, 1 dose of Zicam and 1 lozenge does the trick! It's a great product and we will simply use it in the other forms.

[Patiod]

10. Some logical fallacies there

You feel a cold coming on and take Zicam and don't actually get sick - you're assuming Zican is why you're not getting sick.

But I haven't had a cold since I started working out - *I* feel a cold coming on and get a good night's sleep and I don't actually get sick. Is it the gym? Or my diet, hormones, environment, or immune system? I got a cat around the time I started going to the gym. Maybe the cat helps me avoid colds....

The reason doctors want to see data on new drugs is because a lot of them don't believe pharma company claims (whether from Merck/Pfizer/Wyeth or the makers of Zicam or Airborne) until they see that there are good, well-designed studies that show statistically significant differences between the groups taking the drug and the group taking placebo (either placebo or the gold standard current treatment, since sometimes you can't moraly give someone No Treatment/Placebo).

Well-designed studies on the effect of zinc on colds has not shown any benefit. Airborne doesn't offer legitimate studies either - when reporters tracked down the source of their studies, it was a private house in Florida, and there were no real records.

As for pharma companies wanting to "shut down" zinc, that's nonsense - if it actually worked, they would be more likely to co-opt it. Look how they've all incorporated vitamin D into their osteoporosis products. But if it doesn't work, the FDA won't let them incorporate it, so they haven't.

If you think the FDA is in drug-maker's pockets, you should see how many Big Pharma drug teams I've worked with that have been shot down by the FDA, God bless them. If the data doesn't show that the drug is clearly better than stuff that's currently on the market, it's not approved. You may think the FDA is on the drug-makers payrolls but it sure doesn't seem that way when you're devoted years to a drug, and the FDA comes down on them either for 1) lack of efficacy data on a new drug or 2) side effect data on an existing medication. One of our biggest accounts is going away, along with my job it looks like, because the FDA is shutting the drug down. Bad for me - good for everyone else.

The point being: personal experience is anecdotal and therefore flawed - data is more reliable.

[laugle]

15. Thanks for the post.

Obviously you have a bias for the big Pharma companies and that's fine, you are entitled to your opinion. I appreciate you stating where you work and I know you will find another job soon.

I stand by my post and my personal experience. Zicam works for us. Maybe you should try it!

BTW, I'm not against the big Pharma companies, but I'm sure we can agree that the FDA needs a major overhaul.

Many folks have had great success with homeopathic remedy's which are not regulated by the big companies. Personally, I believe in modern meds and alternative remedies. But we could go on forever about this.

In closing, I assure you I don't work for the company that makes Zicam. But I find it interesting that 2 products that work for me have Zinc.

Next time you get that nasty sore throat, please try Cold Eeze lozenges, and then send me a PM the next day when it's gone............enjoyed talking with you..............

[Patiod]

16. A civil reply on DU! You made my day!

Wow! Someone disagreed completely with my entire premise, and yet remained civil, and even kind. I'm speechless, given the level of nastiness I've experienced whenever I've ventured outside the Lounge.

But then again, this IS the Lounge, which may explain things...

I do want to clarify that far from admitting to being biased in favor of Big Pharma, I think I'm pretty clear-eyed about them. I know what they do that's evil (obscene levels of lobbying) and I know what they don't do that they're accused of (they don't sit on cures for diabetes and cancer, cures that could help their own families).

And the more I talk to doctors, the fewer drugs of any sort(Rx or OTC) I'll take - I'm pretty much down to aspirin these days.

As for the sore throat, rather than take something with no data and no FDA oversight, I usually just pet the cat, gargle with warm salt water before getting to bed early, and then in the morning - the sore throat is gone! Amazing!! I attribute the disappearance of the sore throat to petting the cat, of course....

[laugle]

17. Glad to make your day!

Your funny......we have 2 cats and that one hasn't worked......LOL

Were big cat lover's, my husband takes care of a feral cat colony too.

I still hope you try 'Cold eeze' lozenges, as far as I know there are no complaints or recalls. I'm a freak about safety and hope you try it! Let me know if you do and we will talk again.

I assume you are in Pharma sales, that's a great job and pays well. You are obviously very bright and I'm sure you will find something in the same industry. Good luck to you.

BTW, homemade chicken soup (jewish penicillin) works great for colds, nothing in there will harm you!

[Patiod]

19. God bless your husband - my SO is heading in that direction

All winter he was been feeding a little fellow that we KNOW is homeless, and now we've noticed that when the stray is done dinner, there are 2-3 other kittys moving in to help with his leftovers. I think some of them have homes, but are just trolling for snacks.

I'm actually in market research, which doesn't pay as well as sales (or give you a car and gas money), but it's fun. I mostly interview doctors about why they chose one treatment over another, but also nurses, pharmacists, and other health care providers. But the most interesing are the patients - they can't believe someone is paying them to talk about their condition! It's interesting work, but even pharmaceutical companies are pulling back these days.

As for chicken soup - it has data behind it! (I'll never forget my neighborhood pharmacist telling me NOT to buy anything for laryngytist, just to go home and start drinking hot liquids - soup, tea, even hot water - and it worked)

Thanks for the tip - see you around DU :hi:

[Indydem]

8. Yeah, so they sponsered limpballs?

The stuff worked! Does that mean we stop using things that work because they pay that fat retard to run his mouth?

Maybe we should boycot GM, Sleep Number beds, and whoever else advertises on his show, and deprive ourselves of some of the worlds best products because we have a beef with him.

Dumb logic. When asked, say you found out about it on the internet.

[underpants]

11. Colbert covered this last night-"the Smell of Freedom" 5:08

http://www.colbertnation.com/the-colbert-report-videos/231610/june-22-2009/zicam-recall

[agentS]

13. "Rush Limbaugh Lie of the Day" has more details

Podcast here:
http://www.conceptualguerilla.com/?q=node/2865

He talks about it halfway thru the podcast and plays a few clips of Rush's response, before he tears Rush's ass off.

Rush Limpdick is complaining that this is a "Clintonista conspiracy" to cripple this company and that the plaintiffs are faking it- losing their sense of smell. He think the Dems are out to get him and this is one of those tactics.
At the end of the podcast Rush mentions emails from people who took the drug on his behalf and thusly lost their sense of smell. He calls them agitators.

I hate Rush with a passion. I'm not a big Clinton fan but I'm 100% certain they're not faking lawsuits because of Lewinsky drama.

This is a good argument for the fairness doctrine- only in my version, there's another person in the booth, with a buzzer, so whenever a radio host lies on air, the buzzer gets pressed and it goes "LIAR".
The Clintonistas "LIAR"
The Drive-by media are lying about me again "LIAR"
Barack Obama is a Muslim in "LIAR"
Sotomayor needs to get back in the kitchen and "LIAR"

[Contrary1]

14. Even his editors are idiots...

"...and actually have always thought that you're ads for it were really hooey, you know.

[SidDithers]

20. Matrixx paid $12 million in settlement to 300 people...

who lost their sense of smell back in 2006. They knew they were selling a dangerous product, but because it was labeled "homeopathic", they were exempt from FDA regulations.

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

The irony is that because zicam was such an un-dilute homeopathic product, it still had enough of an active ingredient to actually be dangerous. At 2X dilution, it still contained 2 parts per 100 of zinc. Most homeopathic "remedies" are so highly diluted that there is no chance that they contain even a single molecule of the original ingredient. A 30C dilution has a ratio of 1 part active ingredient per 1,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000 parts water. (yes, that 60 zeros) For that 30C dilution, if you had one molecule of active ingredient, it would be dissolved into a sphere of water 30 billion times the size of the Earth.

Lastly, researchers have been using intranasal zinc for years to induce loss of sense of smell in lab animals.

If you want to use homeopathic zinc as a cold remedy, at least look for dilutions above 12C or 24X. Then there won't be any chance of you killing your nose (or doing anything else for that matter).

Sid


Edit: spelling