Man who lost sense of smell assumed Zicam safe
June 18, 2009 By JEFF DONN , AP National Writer
In this March 20, 2009 photo, David Richardson holds a glass of wine up to his nose at his home in Greensboro, N.C. Richardson suffered a loss of smell and taste after using a Zicam product. (AP Photo/Chuck Burton)
(AP) -- He was like millions of other consumers who sometimes take vitamins or echinacea, hoping to build up his immunity or ward off a cold. He figured alternative remedies were as safe as a spoonful of honey. But that notion washed away with one squirt of a homeopathic cold gel.
David Richardson, of Greensboro, N.C., is one of hundreds of patients across the country who have lodged complaints about Zicam Cold Remedy, saying it destroyed their sense of smell.
"It's like watching a sunset in black and white. The things that you take for granted, not only smelling fresh-cut grass or bread in the oven ... you miss those parts of your life," he says. "There's not a day that goes by that you're not reminded of it."
The U.S. Food and Drug Administration says that people who can't smell may also miss danger signs in their daily lives like smoke or gas. It moved to force three Zicam products - Zicam Cold Remedy Nasal Gel, Nasal Swabs and discontinued Swabs in Kids' Size - off the market Tuesday and told consumers not to take them anymore.
Zicam belongs to an under-the-radar but legal sector of the drug industry called homeopathic remedies. They hold a unique legal status: They are mainly sold without prescription as legal drugs claiming to treat specific ailments, yet they are not routinely reviewed for safety or benefit by the FDA. The agency rarely acts unless safety questions arise after marketing.
Most scientists say homeopathic remedies contain active ingredients in such low concentrations - often 1 part per million or less - that they are usually safe.
But FDA spokesman Sandy Walsh says that "consumers purchasing homeopathic products should be aware that they have not been reviewed by the FDA."
Zicam's maker, Matrixx Initiatives, of Scottsdale, Ariz., contends Zicam is safe. It blames the apparent side effects on the colds and infections that people were treating, not on the treatment. However, the company agreed to suspend shipments and reimburse customers who want refunds.
It already agreed to settle about 340 Zicam claims for $12 million in 2006. It was still dealing with 17 lawsuits earlier this year, as well as more than 500 more patients who may sue in the future, according to its filings to the U.S. Securities and Exchange Commission.
Richardson, 46, says he used Zicam just once. His mother, a retired nurse, offered him some for his stuffy nose. He had just started a new job as a salesman and wanted to work at his best.
So he held the nasal gel to his nose, pumped and inhaled. He immediately felt a burning sensation but acknowledges that his sense of smell was already diminished by the cold. It was only when health returned - but not sense of smell - that he began to worry.
He went to the doctor and had an MRI, but nobody could figure out what was wrong. It was only when he did an Internet search for Zicam and saw all the lawsuits that he began to feel suspicious. One doctor has now tested his sense of smell and tentatively linked the problem to Zicam.
With months of medical care, Richardson says he has regained about 20 percent of his sense of smell.
He has complained to the FDA and engaged a personal injury lawyer but hasn't yet sued. "It finally feels good to feel like we're being heard," he said of the FDA's action.
©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Jun 16, 2009 |
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Companies who break laws slapped on the wrists and continue doing the same. Insurance companies increasingly encourage OTC uses by denying coverage of the exact same medication given Rx increasing the out of pocket expenses for many who can little afford it. Patents and the patenting process for those billions and saving a brand name is restored in the OTC market once the Rx patent expires. The OTC market encourages self-diagnosis and treatment without the critical information/education to do so.
Rx/OTC/Supplemental drugs are produced overseas and if not, the core ingredients are supplied from overseas sources. The FDA is impotent in overseeing even serious sole source medications used in hospitals for quality and efficacy. The Heparin deaths, which continues, just one example. People in hospitals do not have a choice in what is delivered to them, this isn't a place where the buyer can beware or that hallowed free market enterprise can exist.
Indeed, the FDA has shown its impotence through the plethora of new Rx medications that met criteria through the 'research' process only to be pulled off market when applied in the general population and serious problems developed.
The lack of serious consequences to companies who produce
products, gave up their own quality assurance controls, for that extra 1/4cent profit quarterly profit report, (actually it is more like 1000%) means patients are nothing but tools, no service is actually provided. Even when companies have shown themselves irresponsible, they stay in business with tepid responses in consequences to this behavior both in the marketplace and in government.
Why anyone trusts what the FDA says of does now is beyond me including dictating what is 'healthy' and what isn't, how realistic their 'guidelines' are based on 'research' that is just as tainted as the pet food, peanuts and Heparin with many unsuspecting/unaware paying the ultimate price for their incompetence. But wait! Now they are seeking more power since they've done such a good job and they got it too. Rather than addressing what are clear failures first, they will expand and dictate to the masses unaware of their own roles in the failures to serve in the public interest. That foundation crumbled long ago.
For those of you who believe the herbal, "all natural" and other supplemental health products are better, think again. Its all coming from sources that can say anything they want and even put "all natural" sand in those capsules without anyone peering over their shoulders or providing proof beyond the internally generated testimonials.
Woe be those who are really ill, its a crap shoot.
Manufacturer just put zinc at wrong place of human body - to the nasal mucous membrane. Similar cases often occurs with official drugs.
Indeed, it contains an active ingredient as opposed to real homeopathic medicine which contain no active ingredient.
A medication strong enough to cure is strong enough to harm. This manufacturer was using the homeopathic label to get away without adequate testing since homeopathic medicine contains no active ingredient and therefor requires no testing to ensure that it is safe.
The US Congress intentionally created a class of OTC products (homeopathic, herbal, nutritional supplements, etc.) that are not under the jurisdiction. This set free an industry that now in the hundreds of billions of dollars of quack products.