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Zicam Recall: Are the Critics Contradicting Themselves?

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The Celebrex and Vioxx debacle, the Rezulin recall, and many other problems have raised concerns about the FDA’s ability to address prescription drug safety. Whistleblowers, including FDA drug researcher David Graham, have made national headlines with Congressional testimony taking the FDA to task.

The FDA has now taken action against two homeopathic remedies, Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs. Three clinical studies at Dartmouth and the Cleveland Clinic documented Zicam’s efficacy in 2000. But the FDA has received about 130 complaints alleging loss of smell after using one of these two products. There were, however, no cases of anosmia—loss of the sense of smell—in the clinical studies.
Even though no studies have demonstrated a link between the use of these two products and loss of smell, Zicam manufacturer Matrixx Initiatives has offered a full refund to all consumers who purchased these products. Matrixx maintains the FDA’s move was “unwarranted” and the products are safe. Matrixx points out that sinusitis and rhinitis, which often accompany the colds and allergies for which Zicam is used, are themselves causes of the loss of smell.
Many media stories have created a frenzy about the safety of homeopathic remedies. For example, they continue to mention that intranasal zinc has been linked to loss of smell dating back to 1930. They fail to clarify, however, that it was zinc sulfate which was linked to loss of smell. Zicam is zinc gluconate in a homeopathic dilution.
In fact, homeopathic solutions are greatly diluted concentrations. Zicam is one part of zinc gluconate to 100 parts of solution—so as you can see, Zicam users are hardly mainlining zinc! We should also note that critics of homeopathy usually scoff at the dilution factor, and take the position that anything so diluted cannot have any effect at all. If that is true, then it’s hardly fair that the same critics can come back and allege that homeopathic products are dangerous. These two positions are mutually contradictory. Are homeopathic products ineffectual placebos, or are they dangerous? Or does the truth lie elsewhere, that homeopathic products are generally very safe but also in many cases extremely effective?
A recent AP news report described homeopathy as a system of medicine developed from the “fanciful” mind of Dr. Samuel Hahnemann. But homeopathy cannot be so easily dismissed. The first national medical society in the United States was the American Institute of Homeopathy, founded in 1844. By 1900, there were 22 homeopathic medical schools and over 100 homeopathic hospitals. In 1938, Dr. Royal Copeland, a homeopathic practitioner elected to the US Senate, sponsored the Feder¬al Food, Drug and Cosmetic Act that incorporated homeopathic medicines into federal law. Homeopathic remedies have been widely used in Europe for well over 150 years, clinical studies have been published in major medical journals, and the remedies have a long history of safety.
Homeopathic remedies are distinct from dietary supplements and herbs, which are recognized as foods and thus cannot be marketed for the treatment of specific disease conditions. Homeopathic medicines are drugs that can be marketed for specific conditions. According to US law, a homeopathic medicine can be sold to consumers so long as the ailment for which it is claimed to treat has an “OTC indication.”
Go to to read more from the National Center for Homeopathy.
Pulse of Health Freedom June 30, 2009

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