Making the news in the holistic health-care world this week is the recall of Hyland's Teething Tablets.
First, the chuckle: It's FDA-approved to use Botox (a neurotoxin, yes?) to treat certain illness, but it's FDA-banned to use a homeopathic (natural, yes?) to treat a different issue?
Second, the concern: Understanding the questions that have been raised about the manufacturing inconsistencies, I still find the language of the FDA release and Q&A nearly as much cause for concern as the issue itself.
Viewing the statements from the company about its "voluntary" recall, there seems to be a major disconnect between the fundamental language in the respective pieces. Witness: "The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy" and "homeopathic medicines are regulated as drugs by the Food and Drug Administration (FDA), as required in the Food, Drug and Cosmetic Act." Likewise, "Adverse events have been reported but the FDA has said that a conclusive link has not been determined" versus "FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity."
So is the FDA recommending my family discard a product with a (anecdotal) track record of success in our use because of ... hearsay? Has the FDA evaluated the product or not? Given the small quantity of the substance at issue in the product, what range of inconsistency in quality control has been found? Are we talking about a level that can cause this toxicity? The company denies this ("After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers.") but the FDA offers no specificity in its statements and openly states that it has not conducted a safety evaluation of the product itself.
Manufacturing issues are no laughing matter. But neither is a governmental insistence on a product ban (because that is what this amounts to) without concrete evidence of the danger of the product. Would the public not have been better served by an evaluation of the safety of the (inconsistent) product and a demand that the company fix its manufacturing process, possibly even requiring a hold on further manufacturing until satisfaction is achieved? The screaming subjectivity of the first article linked above may not be the fairest portrayal of the situation. But the entire affair certainly reeks of what I have come to think of as Big Pharma as Big Brother.
Better safe than sorry, or another case of Big Pharma's influence-creep?
First, the chuckle: It's FDA-approved to use Botox (a neurotoxin, yes?) to treat certain illness, but it's FDA-banned to use a homeopathic (natural, yes?) to treat a different issue?
Second, the concern: Understanding the questions that have been raised about the manufacturing inconsistencies, I still find the language of the FDA release and Q&A nearly as much cause for concern as the issue itself.
Viewing the statements from the company about its "voluntary" recall, there seems to be a major disconnect between the fundamental language in the respective pieces. Witness: "The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy" and "homeopathic medicines are regulated as drugs by the Food and Drug Administration (FDA), as required in the Food, Drug and Cosmetic Act." Likewise, "Adverse events have been reported but the FDA has said that a conclusive link has not been determined" versus "FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity."
So is the FDA recommending my family discard a product with a (anecdotal) track record of success in our use because of ... hearsay? Has the FDA evaluated the product or not? Given the small quantity of the substance at issue in the product, what range of inconsistency in quality control has been found? Are we talking about a level that can cause this toxicity? The company denies this ("After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers.") but the FDA offers no specificity in its statements and openly states that it has not conducted a safety evaluation of the product itself.
Manufacturing issues are no laughing matter. But neither is a governmental insistence on a product ban (because that is what this amounts to) without concrete evidence of the danger of the product. Would the public not have been better served by an evaluation of the safety of the (inconsistent) product and a demand that the company fix its manufacturing process, possibly even requiring a hold on further manufacturing until satisfaction is achieved? The screaming subjectivity of the first article linked above may not be the fairest portrayal of the situation. But the entire affair certainly reeks of what I have come to think of as Big Pharma as Big Brother.
Better safe than sorry, or another case of Big Pharma's influence-creep?
Post a Comment