Effect Measure

If you smell, here’s a remedy

If you don’t want to smell, the FDA has a recommendation: use an over-the-counter cold remedy that contains an intranasal zinc solution. You won’t smell. Possibly ever again:

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. (FDA Press Release)

Losing your sense of smell is no joke. It is intimately involved with your sense of taste and is a warning sense for dangerous gases. The role of zinc in destroying a sense of smell is not a secret, either. It’s been known for years. The one thing zinc doesn’t seem to do is prevent you from getting a cold. So it can’t pass any FDA test for safety or efficacy. So why was it allowed to be sold over-the-counter? Orac at Respectful Insolence has covered this thoroughly. An especially good AP story by Jeff Donn identifies the culprit as a Trojan Horse clause stuck into the 1938 Food and Drug law by a powerful New York Senator who also was a licensed homeopath. Here’s Orac:

Basically, this law results in automatic approval of drugs that appear in the Homeopathic Pharmacopoeia are given automatic FDA approval, no science, evidence, or messy clinical trials needed. Talk about a double standard! True, most homeopathic remedies are mostly water or alcohol, but a lot of them are adulterated with real drugs–like Zicam, which contained enough zinc to fry the smell receptors of a number of people to the point where they lost their sense of smell. (Orac, Respectful Insolence)

As Orac points out, true homeopathic remedies aren’t likely to hurt you in themselves for the simple reason that orthodox homeopathic practice prescribes serial dilutions so large that it is unlikely the patient gets even a single molecule of the intended active ingredient. But regulation because of this clause is so lax that there isn’t even a check to see if the ingredients are as claimed, and many are certainly at levels that aren’t by any stretch of the fertile homeopathic imagination, “homeopathic.”

So if there’s no effective regulation, what remedies are available for someone harmed by the negligence of a manufacturer who ignores abundant evidence that his product is harmful? Essentially the only remedy is a civil suit, a claim for damages as a result of harmful and negligent actions of another. And that’s happened. While the Bush FDA was asleep at the switch, patients sought legal remedies in civil court:

Zicam seller Matrixx Initiatives, of Scottsdale, Ariz., which grew out of a chewing gum company, paid $12 million in 2006 to settle lawsuits with about 340 Zicam patients. It has won a lawsuit in California, and several other federal cases were dismissed.

[snip]

The company, which has sold more than 1 billion doses since the products came to market in 1999, says it settled in the past simply to reduce its legal exposure. The remedy has recently been sold with a redesigned spray nozzle, and the company argues that it is safe, citing academic studies that it funded. Matrixx says some people failed to follow package directions and stuck the nozzle too far up their noses.(Jeff Donan, AP)

As a result of the FDA advisory, Matrixx has stopped selling its product (Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs) and offered refunds to consumers who request them. But it clearly admits no wrong. AFter all, what could be wrong with selling — legally, it seems — a billion little olfactory nerve grenades. And this is just the tip of the “trust me” homeopathic medicine racket:

Almost reduced to obsolescence in the United States, homeopathic remedies have revived in recent decades with the burst of interest in vitamins, herbs and other unconventional treatments. Since 2002, the U.S. homeopathic remedy market exploded by 89 percent to an estimated $830 million last year, according to market research company Mintel. By 2007, homeopathic remedies were taken by almost 4 million Americans, or 2 percent of adults, federal data show. (Jeff Donan, (Jeff Donan, AP)

What’s in them? Good question. Here are a few answers:

At least 20 ingredients used in conventional prescription drugs, like digitalis for heart trouble and morphine for pain, are also used in homeopathic remedies. Other homeopathic medicines are derived from cancerous or other diseased tissues. Many are formulated from powerful poisons like strychnine, arsenic or snake venom. (Jeff Donan, again)

I’m not a crusader against unconventional medicine. Other things are more important to me, although I respect (insolently, perhaps) those like Orac who are infuriated by the damage done to those who delay or refuse effective treatment because they are hoodwinked by quacks. Of course I recognize that much of conventional medical treatment can also be extremely harmful, even when done with the best intentions. But I am offended by those who harm negligently and without the best intentions, driven only by the desire to make a buck by taking advantage of gullibility or desperation. There’s a loophole in drug regulation and these bastards have been driving their Hummers and Cadillacs through it at full speed.

Maybe the victims here have lost their sense of smell, but they sure know when something stinks.

Comments

  1. #1 Joe
    June 22, 2009

    Recently several medical blogs have devoted a lot of space to problems with Zicam. Fair enough. But it would be nice to see some space devoted to similar problems with pharmaceuticals. For example statins, which some doctors hand out like candy, have been found to have serious side-effects. Here are two studies:

    1. “Considering that tens of millions of Americans now take statins to lower cholesterol, the following headline was conspicuously absent from the major media: “Statins Found to Turn On Gene that Causes Muscle Damage.” It’s now a fact of science; a recent study shows that taking statins destroys your muscle to a greater or lesser degree. And let’s not forget that the heart is a muscle.”

    http://www.wellnessresources.com/studies/entry/statins_can_turn_on_a_gene_signal_that_damages_muscles

    2. “The study is the first to connect the mitochondrial statin dots, a revelation that proves beyond any doubt that statins are too dangerous to consume for almost anyone. Serious side effects include loss of muscle function, cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction. These side effects are worse in people with genetic susceptibility, in combination with other drugs, or in the presence of other energy related problems such as thyroid disease.”

    http://www.wellnessresources.com/studies/entry/statin_side_effects_are_plentiful_and_serious

  2. #2 Leigh Ann
    June 22, 2009

    OK, I officially award this blog Best Zicam-Story Title. The first paragraph is awesome too. Thanks for the grin.

    Leigh Ann Otte
    Managing Editor
    My Family Doctor magazine
    Written by health-care providers for the general public.

  3. #3 Lisa the GP
    June 22, 2009

    OT: got any heat-wave safety advice?

    I’m not in an affected region but it might be a timely topic.

  4. #4 Hank Roberts
    June 24, 2009

    Another one to beware of, widely available last I looked:

    Nasal-Ease
    Nasal Spray Moisturizer with Zinc Gluconate
    “Drug Free”
    from:
    Health Care Products
    Consumer Care Division
    a division of Hi-Tech Pharmacal Co. Inc.
    Amityville, NY 11701

    Nasal Ease
    Our site is temporarily unavailable. Please check back soon.
    http://www.nasaleaseblocker.com/

    Reported problems to the FDA, about a decade ago.
    Never got any response.

    Sniff.

  5. #5 davidhartley.com
    June 24, 2009

    Zicam – lost sense of smell – cure by homeopathy

    Zicam was recently removed from the market by FDA due to fraudulent labeling .. which was discovered as a result of numerous complaints of loss of sense of smell.
    The labeling was a fraudulent offering for sale “an unapproved drug” .. by claiming unwarranted OTC status as homeopathic remedy. Zicam IS NOT a homeopathic remedy…
    -and luckily any loss of sense of smell caused by Zicam is very likely curable by homeopathy.

    Searching ‘loss of sense of smell’ in the Radar 10 homeopathy software database, I find 106 homeopathic remedies listed.On the good side, that means that a professional homeopath will undoubtedly be able to cure a loss of sense of smell due to either high sensitivity to –or perhaps overuse of zicam, which contains Zinc, the active ingredient identified as likely cause of loss of smell.
    On the downside .. so many choices means that it is much less likely that DIY use of homeopathic remedies will cure (this is basically true in almost any instance other than first aid; the most famous homeopathic remedy in first aid is Arnica for bruising & trauma; naturally loss of sense of smell is not your typical first aid situation.)

    San Francisco bay area homeopath:
    http://www.holistiq.com -referrals available in other areas.

    Maxxim, makers of Zicam, have seen their stock drop +/- 80% prior to being frozen from further trading.
    Hopefully, this will send a message to other pharmaceutical type companies who think it might be clever to try to take advantage of homeopathic remedies’ Congressional approval as OTC medications within the strictly delineated labeling standards and in accord with HPUS, the U.S. Homeopathic Pharmacopoeia.

    Homeopathy is a medical system with medical residencies & training in hospitals .. in India and other places where it is not rigorously suppressed by $pharma & AMA with all their ‘skepdic’ internet trolls; thanks to this suppression by $pharma, you have fewer choices in medical care, and thus are more likely to buy-in to the $300 Billion in annual $pharma sales .. all of which contributes to $pharma being recognized by health experts as #1 leading cause of death in the U.S. see
    http://www.whale.to/a/dean.html
    as a starting place on the epidemic of Death By Doctor

    and now for some voices of hope & good cheer:
    http://www.MakePeaceBrothers.com/Hero

    Tags: zicam, $pharma, cure, fda, fraud, homeopathic-remedy, homeopathy, homeopathy-community, homeopathy-world-community, hpus

  6. #6 Hank Roberts
    June 24, 2009

    Good grief these people are scum:

    How to Keep Your Nose Healthy, Wealthy and Wise – PR Newswire …
    Here are some tips for an uncommon edge against the common cold from the experts who bring you Nasal-Ease Nasal Spray Moisturizer with Zinc. …
    http://www.encyclopedia.com/doc/1G1-20073570.html

  7. #7 Lenn
    June 24, 2009

    I don’t want to cause a stink (no joke intended), but I just wanted to say that I’ve used Zicam for several years now and it has never caused a problem with my sense of smell, and it has always worked, when what I had was a cold.

    I originally started taking it on a recommendation from my doctor, and have been very satisfied. He recommended it, even though it was labeled as a “homeopathic” cure, because he believed that it actually worked by inhibiting the replication of the cold virus in some way. Zicam would always get rid of my cold symptoms within a few hours of the first dose, and my cold problem would be solved. The only two times it failed to work for me, my doctor later determined that I had something other than a cold.

    Perhaps the reason it did not effect my sense of smell is that mine is already shot from decades of sinus problems and taking all kinds of other remedies, but I haven’t noticed any further decline on my part.

    Obviously, if this is happening to people, then they need to take it off the market. It does make me sad, though, as I had finally found something to get rid of the colds I seem to catch at least a couple of times a year, and now it’s gone.

  8. #8 M. Randolph Kruger
    June 24, 2009

    Lisa, ever noticed how every Vietnam movie had a guy with a green towel around his neck? Thats your recipe for not getting dead from heat stroke. Makes a good wet tent over the head, keeps the neck cool too. As long as you dont wear white ones, then neither the VC or the Taliban is going to notice you wearing it. Been in one for over two weeks now in Memphis…Temp 113-119 on the airport ramp.

    As for Zicam. Urps, thats the nasal solution stuff. The swabs are probably just as bad though. Either way, I take my zinc in my daily vitamin and not intra-nasal. Revere may or may not know it, but its based upon zinc swimming pool technology to keep the bacteria/virus levels down. They are in use all over the South. Me, I like the chlorine because the mosquitoes hate it.

    Back to Zicam…They have been pulled but you think this set Revere off…Wait til he reads this.

    http://www.bizjournals.com/phoenix/stories/2009/06/15/daily49.html

    Oh…UHC warning label. Dont go to Australia. They are almost out of beds and are completely out of intensive care beds in Victoria. Thats for that mild flu thing down there.

  9. #9 revere
    June 24, 2009

    Randy: What does a hospital full of flu cases have to do with UHC? Are you saying they do’t need to be in the hospital? Or that our hospitals won’t be full, even in a mild flu pandemic? Or is this just like tapping on your knee and making you say by relfex, “UHC. UHC. Save me!”

  10. #10 M. Randolph Kruger
    June 25, 2009

    No Revere, just stating the facts that they are now at capacity. Those words, “decisions are going to have to be made” from the MOH there are about to come true. From friends other than Jonny S. I am told that there is a police presence outside every hospital now. I personally think that the Obamanation plan is going to collapse the healthcare system here and the federal budget. We will have to wait and see. It might not pass once the real numbers start rolling in. Clinton planned to use it as a cash cow, but now it will very likely result in no care for most everyone or shitty care for everyone.

  11. #11 Hank Roberts
    June 25, 2009

    Revere(s), what’s the current appropriate practice for testing smell? Over the last dozen years I’ve asked my last four primary care doctors (high turnover in our area) to test mine, each has said they would look into it, then left the practice of medicine before getting around to it. The new doctors coming in don’t know anything about this.

  12. #12 revere
    June 25, 2009

    Hank: In my day we carried small vials in our bags (coffee, perfume, can’t remember what else) to test the first cranial nerve (the olfactory nerve). There is a formal method for odor sensitivity based on a panel of odorants at various dilutions, but few if any docs know anything about it or have the panel. It is usually done by specialists. That’s all I know. If you find out more, post it here.

  13. #13 Prolix
    June 25, 2009

    But regulation because of this clause is so lax that there isn’t even a check to see if the ingredients are as claimed.

    I give up. How do you test a homeopathic medicine to see if it contains the claimed ingredients?

  14. #14 revere
    June 25, 2009

    Prolix: If it has only water, it is homeopathic.

  15. #15 Erin R
    July 1, 2009

    Long before the Zicam-nose explosion, I had been curious about orally taking something containing large amounts of zinc, like the Zicam melt-in-your-mouth tablets. Is it possible that those could cause a loss of taste?

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