Deadly Nightshade: Do Not Eat | Photo: Joan Simon, CC BY-SA 2.0
I’ve written on here before about the insanity of even the basic concept behind homeopathy — the magical thinking that suggests infinitesimal amounts of often very poisonous things can cure unrelated ailments. I’ve also written about the dangers of an underpowered regulatory drug agency. But a new exposé in STAT suggests that the current state of affairs in America combines the two to potentially deadly effect.
STAT is a project of Boston Globe Media that’s run by Rick Berke, whose career highlights include New York Times chief political correspondent, NYT assistant managing editor, and Politico executive editor. Started in 2015, the publication describes itself as “focused on finding and telling compelling stories about health, medicine, and scientific discovery.” This latest piece has the same old-school journalistic feel of the better days of the Boston Globe, as it details case-by-case the complaints against one of the largest homeopathic “remedy” producers in the US, Hyland’s.
You should go read the piece yourself. By Sheila Kaplan, it’s called “Homeopathic remedies harmed hundreds of babies, families say, as FDA investigated for years,” and it does precisely what you’d expect from the title. One complaint at a time, it builds a case for a trend of dangerously poor controls in the manufacturing of Hyland’s products, most specifically the amount of belladonna in their “homeopathic teething remedies.” Belladonna is, of course, deadly nightshade.
In theory, homeopathic products should contain literally zero of their “active ingredients.” As I’ve written before about cold “remedy” Oscillococcinum, the standard homepathic dilution ratio is what they call “200C” — one part in a hundred, then one part of that in a hundred, then one part of that in a hundred, two hundred times:
This is why homeopathy purveyors can claim their teething products are 100% safe. They know that if they’re being made correctly there’s nothing in them but filler.
But that doesn’t mean they can’t do harm.
“Over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel, a similar product that is applied directly to a baby’s gums. Agency records show eight cases in which babies were reported to have died after taking Hyland’s products, though the FDA says the question of whether those products caused the deaths is still under review.”
There is a remarkable lack of regulation of homeopathic products in America. Unlike drugs, which need to demonstrate both safety and efficacy, homeopathic products don’t. Of course they can’t demonstrate efficacy, because having no active ingredients they can literally be no more effective than their inactive ingredients. But they also don’t have to guarantee their manufacturing processes. If someone screwed up and didn’t dilute the definitely poisonous belladonna in the teething products enough, you’d have parents literally poisoning their kids.
Here the article dances around that possibility — it’s not something they can prove, which is why Hyland’s is getting away with it.
“…the episode underlines the cracks in the agency’s regulatory power when it comes to homeopathic products. There is no set mathematical formula or official standard that spells out how many sick or deceased children must be reported before the FDA seizes a company’s inventory or levies fines or shuts it down.”
In order to prevent the sale of these products, the FDA would have to take Hyland’s to court, and there’s no guarantee they could win, even if there is a great deal of suspicion that their products are causing harm.
The takeaway is this: even if you’re using homeopathy for something non-life-threatening, where substituting something that doesn’t work for actual medicine won’t itself passively cause harm, there simply isn’t enough regulation of homeopathic products in America to guarantee that they don’t contain things that will actively cause harm.
Don’t use homeopathy. The best case scenario is you’ll waste your money on nothing. The worst case scenario is far, far worse.
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Richard Ford Burley is a human, writer, and doctoral candidate at Boston College, as well as Deputy Managing Editor at Ledger, the first academic journal devoted to Bitcoin and other cryptocurrencies. In his spare time he writes about science, skepticism, feminism, and futurism here at This Week In Tomorrow.