Homeopathic product recall
Today, the US FDA warned consumers to immediately stop using the product Zicam, a homeopathic remedy, because it may cause anosmia, the loss of sense of smell. The FDA has received over 130 adverse reports from consumers who believe that they suffered anosmia after using Zicam.
Zicam is marketed a Big Herba company, Matrixx Initiatives, Inc., and is sold as a remedy for relief of symptoms of colds, flu, and allergies (all with different causes). There is little or no evidence from respected peer reviewed journals that zinc gluconate, the active ingredient in Zicam, has any effect on the course, duration, or severity of common upper respiratory tract infections. The Cochrane Reviews state that, the “evidence of the effects of zinc lozenges for treating the common cold is inconclusive.” Infectious disease researchers from Stanford University have concluded that most positive studies of zinc gluconate are flawed in design and that the “therapeutic effectiveness of zinc lozenges has yet to be established.” A well designed double-blind study published in Clinical Infectious Diseases concludes that the “data do not support a role for intranasal zinc gluconate for prevention or treatment of the common cold.”
In support of Zicam is one study, that Matrixx hypes on its website, gives some positive results, but the populations are so small (40 patients) that it cannot be reliably interpreted. In fact, the statistical analyses depend on one result in many cases. That is no better than flipping a coin once. Furthermore, Matrixx approved the submission of the article to a journal (and presumably funded the study). Actually, I don’t consider corporate funding and control of publication to be a serious issue, but how many times do I read the woo-pushing crowd accuse Big Pharma of doing the same–so for me, this is just part of the whole Big Herba hypocrisy.
Nevertheless, Zicam probably is no more or less effective than a placebo, so it may benefit those individuals who benefit from placebo effects, if they exist. The problem is that there appears to be a risk from the product. So, it may not be efficacious and it may not be safe. Until the company proves that the product is safe and efficacious, Matrixx needs to adhere to the standards of any pharmaceutical company–prove it.
Typical of Big Herba, Matrixx is making all kinds of claims on its website on how the FDA has it all wrong. And of course, stating that they have medical and scientific evidence for the safety and efficacy of Zicam, though my brief review of the research indicates it’s probably not effective, and little research on safety. The alt-med woo-pushing crowd would, of course, be all over Big Pharma if this happened to them. Let’s see what happens to the product that is arguably the biggest selling homeopathic remedy ever.
By Michael W Simpson
Zicam is marketed a Big Herba company, Matrixx Initiatives, Inc., and is sold as a remedy for relief of symptoms of colds, flu, and allergies (all with different causes). There is little or no evidence from respected peer reviewed journals that zinc gluconate, the active ingredient in Zicam, has any effect on the course, duration, or severity of common upper respiratory tract infections. The Cochrane Reviews state that, the “evidence of the effects of zinc lozenges for treating the common cold is inconclusive.” Infectious disease researchers from Stanford University have concluded that most positive studies of zinc gluconate are flawed in design and that the “therapeutic effectiveness of zinc lozenges has yet to be established.” A well designed double-blind study published in Clinical Infectious Diseases concludes that the “data do not support a role for intranasal zinc gluconate for prevention or treatment of the common cold.”
In support of Zicam is one study, that Matrixx hypes on its website, gives some positive results, but the populations are so small (40 patients) that it cannot be reliably interpreted. In fact, the statistical analyses depend on one result in many cases. That is no better than flipping a coin once. Furthermore, Matrixx approved the submission of the article to a journal (and presumably funded the study). Actually, I don’t consider corporate funding and control of publication to be a serious issue, but how many times do I read the woo-pushing crowd accuse Big Pharma of doing the same–so for me, this is just part of the whole Big Herba hypocrisy.
Nevertheless, Zicam probably is no more or less effective than a placebo, so it may benefit those individuals who benefit from placebo effects, if they exist. The problem is that there appears to be a risk from the product. So, it may not be efficacious and it may not be safe. Until the company proves that the product is safe and efficacious, Matrixx needs to adhere to the standards of any pharmaceutical company–prove it.
Typical of Big Herba, Matrixx is making all kinds of claims on its website on how the FDA has it all wrong. And of course, stating that they have medical and scientific evidence for the safety and efficacy of Zicam, though my brief review of the research indicates it’s probably not effective, and little research on safety. The alt-med woo-pushing crowd would, of course, be all over Big Pharma if this happened to them. Let’s see what happens to the product that is arguably the biggest selling homeopathic remedy ever.
By Michael W Simpson