Use It or Lose It

Whenever an over-the-counter medicinal product is on the evening news, it’s never a good thing. The other night I watched as my beloved Zicam Cold Remedy was plastered across the headlines. The reporter did a profile story on this poor bloke who apparently lost his sense of smell after using Zicam. I’m not trying to dismiss this man’s quandary, because losing your sense of smell (or any sense for that matter) sucks, but I found a bit of humor in the way the story was presented. It was a “woe is me” exposé on how his smell diminished over a period of time to the point of permanent damage. He took for granted the odorous sensations in life, like the taste of foods and the smell of roadkill, until it was too late.

Not only was Mr. Don Ehler’s story on all the major TV news stations, Zicam became an overnight media buzz on the internet as well, with “Zicam side effects” and “Zicam recall” prominent searches on Google. But what I don’t understand about any of the reporters who covered the story is that they didn’t seem to ask Ehler (or any of the supposed 130 other Zicam consumers who complained of smell loss) how often they actually used the product. I have a hunch that it was not a once-a-month kind of a deal. Admittedly, zinc is a powerful acid and squirting any copious amounts up your nostrils can be hazardous to your health, but I would not be too concerned about using it periodically during the cold season. All drugs have side effects. Anything you put into your body can have unwanted consequences. I don’t think that necessarily should mandate a complete recall of all Zicam’s products (as some are demanding).

I don’t know if I’m being a conspiracy theorist here, but I think the involvement of the FDA in this situation brings up a whole host of other issues. It really is not as black-and-white as a “bad/defective drug.” Lately (including this and that), the FDA has been on a power trip. The government-run organization wants to be control of every aspect of public health. Since 1999, Zicam hit the consumer market as a “homeopathic remedy” and has not needed FDA approval because it was not a “drug.” With the immense popularity of the cold remedy in the last five years or so, they have surely raked in the dough. The FDA clearly would want a piece of this profitable pie. Apparently Zicam’s parent company Matrixx paid $12 million in court settlements filed by Zicam users in 2006, but in the three years since then it has not snowballed into a bigger issue. So when on June 16, the FDA released a warning advising consumers to not use the nasally-administered product at all, some red flags when up for me. It is interesting to note that although Ehler admitted to using (the not-as-popular) Zicam’s nasal allergy spray on a weekly basis, the FDA did not include the allergy products in their action against the company.

If you visit Zicam’s website, the first thing you’ll see is a “Message to Consumers” about the recent FDA warning (with an accompanying video from the president of Matrixx Initiatives). I was actually disappointed to see that the company decided to voluntarily recall their product in compliance with the FDA’s warning. Despite making it clear that their scientific and medical safety tests have shown “no credible evidence that Zicam… causes you to lose your sense of smell,” Matrixx says that they plan to fully cooperate and work with the FDA in getting the issue resolved.

Although anosmia (the loss of smell) is no laughing matter, I think it’s quite humorous that out of all the dangerous diseases that our plaguing our people today (including AIDS, cancer, malaria, TB, and influenza), this is the one (along with the swine flu) that Americans are supposed to be concerned about. I don’t mind my nose; most of the time (when it’s functioning properly), I don’t even notice it at all. I am, however, continually fascinated how memories can be triggered by the sudden onslaught of a particular fragrance. That part of the nose is engrosses me very much. Nevertheless, if I had to lose one of my five senses, it would be smell. I would ultimately chose to keep my vision, hearing, taste, and sense of touch over that distinguishing piece of cartilage in the middle of my face.

The momentary question: Will I continue to use Zicam products? Yes, I will use the oral remedies (if need be) until the nasal ones are back on pharmacy shelves. I don’t use the product habitually, but it really does work for me as a preventative measure when I feel the rhinovirus coming on. I really hate being sick (as though anybody really enjoys it) so, for the time being, it is worth the risk for me.

Lesson of the day: Stop and smell the roses once in a while. They may not always be there. (Apparently some roses are an endangered species.)

Article(s):

Richmond man joins Zicam complaints

FDA says Zicam nasal spray can cause loss of smell

FDA warns against using 3 popular Zicam cold meds

High on Life

Word on the street is that there’s a new drug in town. This one doesn’t get you high, improve your focus, pump your muscles, or give you longer-lasting erections, but what it does do is lower your cholesterol (with diet and exercise). No, it’s not a cousin of Lipitor, Crestor, Zocor, or Tricor. In fact it doesn’t end in “or” and it’s located in a different store aisle entirely. It’s in the cereal aisle.

General Mills’s Cheerios® Toasted Whole Grain Cereal has recently come under fire by the Food and Drug Administration (FDA) for illegally marketing itself as (what the FDA considers) a “drug.” Because a standard box of Cheerios claims “You can lower your cholesterol by 4% in 6 weeks” and “Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease,” it is a misbranded label. If according to the FDA, cereal is a drug then anything we consume can be considered a drug.

The FDA writes in a letter to the company, “[W]e have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.” And as such, Cheerios “may not be legally marketed with the above claims in the United States without an approved new drug application.”

General Mills is being a good sport about the whole thing. They released a statement saying, “The science is not in question … the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong. [...] We look forward to discussing this with FDA and to reaching a resolution.”

I think the whole thing is ridiculous. The FDA is abusing its power by trying to regulate the way a product is advertised. To say an unauthorized health claim on a box of cereal is a violation of federal regulation is an extreme position. Who cares if the claims on the Cheerios box are true? If they make people buy it and eat a healthier cereal (as opposed to really sugary cereals), it’s a win-win. That’s called successful marketing.

So kids, the next time you want to do drugs, try getting high off a box of Life®. Call up the FDA and see what they have to say about that.

Article(s):

Goldstein, Jacob. “FDA Warns General Mills: Cheerios Is a Drug.” The Wall Street Journal 12 May 2009. URL