Beth Mole at ArsTechnica has an article about the levels of belladonna in homeopathic teething products made by Hyland's:
After investigating reports that more than 400 babies were sickened and 10 died in connection with homeopathic teething products, the Food and Drug Administration confirmed Friday that it had indeed found elevated levels of the toxic substance, belladonna, in the products.
Belladonna, also known as deadly nightshade, was the prime suspect of the investigation from the beginning, which Ars reported about last fall. Nevertheless, the products' maker, Hyland's, would not agree to recall the products when it was notified of the FDA's conclusion, the agency reported
In a response to Ars, Hyland's has acknowledged that there are some inconsistencies in the amount of belladonna in its products, but the company said that it has not seen any evidence from the FDA indicating that the elevated levels were toxic or excessive. [...]The FDA said it had found inconsistent amounts of belladonna in Hyland's products. Some of the amounts were "far exceeding" what was intended.
[...] As before, the FDA is urging parents to avoid the homeopathic teething products and toss any already purchased. The FDA does not evaluate or approve the homeopathic products, which have no proven health benefit.
Also: Hylands FAQ about the discontinuation.
(Score: 3, Touché) by Scruffy Beard 2 on Wednesday February 01 2017, @07:32AM
I thought homeopathic medicine was supposed to be essentially, distilled water.
- https://en.wikipedia.org/wiki/Homeopathy [wikipedia.org]
That is to say, if there is any active ingredient in the end-product, they probably screwed up somewhere.
(Score: 2) by Scruffy Beard 2 on Wednesday February 01 2017, @07:49AM
The actual expected concentrations:
Hyland’s Baby Nighttime Teething Tablets -- Belladonna 12X HPUS [hylands.com]
Hyland's Baby Teething Gel -- Belladonna 6X HPUS [hylands.com]
Again from the wiki:
...So it looks like the gel is supposed to have about 1 trillion molecules, while the tablet is supposed to have approximately one.
(Score: 3, Interesting) by Scruffy Beard 2 on Wednesday February 01 2017, @07:57AM
oops wrong scale. (I used the C not X scale for my conclusion)
From the website:
Belladonna 6X HPUS (0.0000003% Alkaloids, calculated):
-> 1/3x10e-9 -> 1: 333 million
Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)
-> 1/3x10e-15 -> 1: 333 trillion
(Score: 1) by khallow on Wednesday February 01 2017, @01:41PM
(Score: 2) by jdavidb on Wednesday February 01 2017, @05:23PM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 2) by krishnoid on Wednesday February 01 2017, @07:45PM
I bet the levels weren't so much inconsistent as the were individually adjusted to the levels of latent lycanthropy in the patients under consideration. That's why it had to be put back on the market -- the master lycanthrope is still on the loose.
(Score: 1) by khallow on Wednesday February 01 2017, @08:50PM
(Score: 2) by LoRdTAW on Wednesday February 01 2017, @01:03PM
I'm pretty sure people might think twice about purchasing it if they called Belladonna by its other name, deadly nightshade. From Wikipedia [wikipedia.org]:
And the first sentence under Toxicity:
I'm at a loss for words.
(Score: 2) by jdavidb on Wednesday February 01 2017, @05:24PM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 2) by dry on Thursday February 02 2017, @02:59AM
It can't be that bad, otherwise our wonderful governments would have illegalized it as they have other harmful herbs.
(Score: 2) by butthurt on Thursday February 02 2017, @05:21AM
The article you linked has seven paragraphs enumerating uses for the plant, or extracts of it, in conventional medicine.
https://en.wikipedia.org/wiki/Atropa_belladonna#Medicinal_uses [wikipedia.org]
(Score: 1, Informative) by Anonymous Coward on Wednesday February 01 2017, @08:39AM
Homeopathy is always worse than placebo, because it is prescribed as a real thing.
I could have died as a kid due to being prescribed homeopathy, when what I actually needed was surgery.
(Score: 3, Insightful) by choose another one on Wednesday February 01 2017, @10:39AM
The whole point of a "placebo", at least in clinical trials, is that you don't actually know whether it is a placebo or the real thing. Homeopathy is therefore exactly the same as a placebo, and just as beneficial, also just as dangerous.
(Score: 0) by Anonymous Coward on Thursday February 02 2017, @06:55AM
I think the parent AC meant to say "placebo effect"; maybe something like: "Because homeopathy is prescribed as a real thing you don't get the benefit of placebo effect".
(Score: 0) by Anonymous Coward on Friday February 03 2017, @03:31PM
No it's not the same. With homeopathy, you know you didn't get the real medicine.
(Score: 4, Insightful) by VLM on Wednesday February 01 2017, @02:28PM
they probably screwed up somewhere
When I took quantitative chemical analysis (admittedly a long time ago) if you're trying to make a liquid standard solution accurate to 3, 4, 5, or more figures it turns out that you have to mix stuff WAY the hell longer than people are used to from mere kitchen cooking or else samples of the "standard" taken from the top or bottom of vessel will be measurably different.
The prof had long stories about this but it was all hand waving and "I'm sure in the reactor module for ChemEng you'll learn all about CFD simulations and rules of thumb".
I remember part of the lab work which we were tested on involving heavy weirdness to make a standardized sodium hydroxide solution, which sucks, intentionally, so we'd learn a little something. Being alkaline it slowly dissolves the glass container which shows up in the deeper decimal places over time and also it sucked CO2 right out of the air lowering its concentration over time. What a PITA.
Then we had to analyze everyone elses standards and they did a giant grid both to grade us on how close we got to the 0.10000... Molarity goal and how screwed up our analysis was of everyone elses work. And the TA participated and basically kicked our butts by using more professional equipment (from memory he used a nitrogen bath to keep air away and redistilled his water under nitrogen, or maybe it was argon, whereas we used the distilled H2O tap, and he did something funky I don't remember to the glass, some kind of pre-rinse). From memory I did pretty well.
Anyway back on topic, big vat of pure water, add a drop of icky, don't mix well, separate the big vat into a bazillion little bottles, kitchen chefs or bartenders would be surprised how poorly chemicals mix compared to human scale experiences with food.
Its "easy" to F this up, is what I'm saying.
Of course being a scientific bastard AND a cheap bastard I know enough that I would be shipping pure distilled H2O and not even buying the toxic stuff to mix dilute, but I'm not a devout homeopath so ...
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @03:13PM
Yep, that whole "so diluted there can't be anything left" argument you always hear is based on some really wrong and incorrect assumptions. So is the "water memory" explanation. It is amazing how easily pseudoscience takes over both sides of debates like this.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @03:40PM
There is nothing wrong with the argument. You're talking about incompetence in preparation, and that has nothing to do with "pseudoscience". For example, the FDA "arguments" for safety in food canning (time, temperature, and pH) are perfectly fine and sound arguments. They aren't "pseudoscience" if a canning facility can't carry them out to ensure it applies to all cans and batches.
The "so diluted" argument is a very compelling theoretical argument against the whole idea of homeopathy; the case for homeopathy only goes down from there if you're talking about not even being capable of ensuring you are diluting toxins down to the levels you say you need to for it to work.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @03:58PM
No, it is pseudoscience when in practice it is very difficult to perform the dilutions they claim. For decades the "skeptics" failed to actually check this and kept on with the same oversimplified theoretical objection to homeopathy's pseudo-scientific explanation. It is idiots on both sides.
(Score: 3, Insightful) by Runaway1956 on Thursday February 02 2017, @02:05AM
*cough*
The difficulty of a process doesn't define how scientific the process is. Did you think it was "easy" for the Manhattan project to achieve any of the steps involved in building fission bombs? Come on - anyone who reads this site can do better than that.
(Score: 2) by FakeBeldin on Wednesday February 01 2017, @08:17AM
Doesn't the FDA have the authority to ban products whose toxicity levels fall well outside established regulations?
If not, someone in government surely does... right? It almost has to be - the USA is not a coast-to-coast environmental hazard.
So there's got to be more to this than "Maker refuses recall, government allows maker to continue selling products that will kill babies".
(Score: 2) by MostCynical on Wednesday February 01 2017, @12:08PM
It's the free market. If the consumer buys it, then it is okay.
The government *warned* people not to buy or use it.
Any more "intervention" would be over-reach, ("big government bad!"), wouldn't it?
/s (although I expect some do believe this)
"I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @01:00PM
Free market capitalism FTW! Hands off my path to profit government! Vote RED!
(Score: 0) by Anonymous Coward on Thursday February 02 2017, @02:26AM
Fucking dumbass partisan retards NEVER seems to understand they're part of the problem.
(Score: 2) by jdavidb on Wednesday February 01 2017, @05:25PM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @05:43PM
It's almost like the distributed, decentralized decision-making of individuals is good enough...
(Score: 3, Touché) by DeathMonkey on Wednesday February 01 2017, @07:25PM
It's almost like the distributed, decentralized decision-making of individuals is good enough...
I think the parents of the ten dead babies would disagree.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @09:09PM
What? You don't want to be naked and locked into your gibbet? Too bad - you shoulda thought about how your personal choices nebulously or homeopathically caused the deaths of ten lives.
(Score: -1, Flamebait) by Anonymous Coward on Wednesday February 01 2017, @08:35AM
Do we finally have an explanation for Runaway1926? Belladonna! And Laudanum. Hillbilly Heroin, before there were Hillibillies or Heroin! Something to do with a White Horse Prophecy, but not Mormon at all. Brain damage. Fox News. Brietfart! All makes sense now. . . . Really!!! Seamonkeys took my hair... Steven Bannon is my love. Why are you all wearing tutus?
(Score: 2) by Azuma Hazuki on Wednesday February 01 2017, @04:15PM
1956, not 1926. His issues can be explained by childhood abuse, then abuse in the armed forces (giving and receiving, no doubt). I'd be surprised if he did any drugs other than the socially accepted ones, tobacco and alcohol.
I am "that girl" your mother warned you about...
(Score: 4, Touché) by FatPhil on Wednesday February 01 2017, @08:35AM
Great minds discuss ideas; average minds discuss events; small minds discuss people; the smallest discuss themselves
(Score: 4, Insightful) by GreatAuntAnesthesia on Wednesday February 01 2017, @09:14AM
Hyland's has acknowledged that there are some inconsistencies in the amount of belladonna in its products
OK, they've been asked, they've been warned, they still refuse to comply... it's time to start kicking some doors in and putting people on trial. I mean, ten dead babies and they still persist? What the fuck is wrong with these people? Also...
the FDA is urging parents to ... toss any already purchased.
I think they mean "safely dispose of this hazardous substance" and not just dump it into the sewers / ground. Surely it would be better to hand it in to a pharmacy, or maybe the FDA could arrange collection and bill the poisoners for the cost..?
(Score: 2, Insightful) by Anonymous Coward on Wednesday February 01 2017, @10:00AM
No, it isn't easy to be sure about these poisonings. Lots of things can lead to similar symptoms. Also, the people using this product are no doubt doing all sorts of non-fda approved things unusual for the population in general, and this population is enriched for groups with certain socioeconomic and genetic attributes. I can tell you that is true without checking TFA on this specific topic because... it always is! Your science training has failed you.
(Score: 2) by jdavidb on Wednesday February 01 2017, @05:18PM
It's also not clear if the people involved were using the product according to the directions, or were giving their kids these pills like rats on a saccharine study. The FDA really isn't releasing a whole lot of actual scientific data, here - just making pronouncements. For what it's worth, as a result of what the FDA said about this last year, Hyland's stopped selling in the US (they still sell in the rest of the world), so it's a bit overblown to complain that they haven't recalled it. Sure, there's still some out there, but it isn't going to last forever.
Also for what it's worth, the FDA has previously taken products for infants off the market simply because they felt parents wouldn't follow the directions, which really isn't fair to those of us who do in fact follow directions.
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 5, Insightful) by sjames on Wednesday February 01 2017, @10:47AM
It would be nice if they would state the actual tests run and the actual amounts found. The last time the FDA went into a tizzy about teething drops, they released a weasel worded document claiming they contained an ingredient that could be harmful in larger doses. A statement that is true of literally every approved drug,
It's worth noting that an adverse event report only claims that something bad happened while a product was in use, not necessarily BECAUSE the product was in use. It's also worth noting that the symptoms of much more serious conditions may initially be mistaken for a reaction to teething and be inappropriately treated.
(Score: 5, Insightful) by Anonymous Coward on Wednesday February 01 2017, @03:56PM
The real issue here is that the FDA has been specifically neutered by lobbying from the multi-billion dollar "natural medicine" industry and the resulting corrupt influence [scienceblogs.com] from Orrin Hatch [newrepublic.com]. If this was real medicine, the onus would be on the provider showing that it is safe. Here, because of Hatch and company, the onus is on the Government to show that it is not safe and the company is basically free to put out anything on the shelf, no matter how dangerous it might be, just as long as they include the weaselly "this product is not intended to treat or cure any disease, etc."
The FDA looks weak and weaselly to you because Hatch intentionally made them that way. They are trying to do their job with one arm tied behind their back, a shackle on their ankle, and a blindfold on, and the result is that people like you side with the snake oil salesmen because you feel the FDA isn't treating them fairly, and then when people really start dying of stuff like this, they jump and down complaining about the incompetent Government not stopping something like this from happening.
(Score: 5, Insightful) by Azuma Hazuki on Wednesday February 01 2017, @04:17PM
Modded up because dammit people need to see this. Thank you for pointing it out. This is yet another example of "starve the beast," where these GOP pissfucks cut funding and power for an agency and then when it fails use that as an excuse to get rid of it.
I am "that girl" your mother warned you about...
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @09:28PM
And just who is going to front the millions of dollars required to prove to the [arbitrary government standards] that the "medicine" is "safe"?
If I find out that chewing tree leaves makes pain go away, and I want to buy those leaves, then get the hell out of my way and let me spend my own earned resources on a product someone else is selling. As long as there is no fraud and no gross negligence, then there is no crime.
The FDA just tried to ban tree leaves [scientificamerican.com] by making them decades-long-felonies to possess. The outpouring of unexpected outrage from people actually caused a change in government policy, a rescinding of said emergency ban attempt [latimes.com]. (Like rust, however, government is ultimately unceasing in its invasiveness and destruction of good things, and therefore it is expected that its efforts to impose a tree leaf ban will continue, most likely when it is anticipated that normal people have stopped paying close attention.)
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @10:00PM
It's called freedom. Nobody is forcing you to buy homeopathic products.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @10:49PM
No, dipshit, its called consumer product safety backed by 100 years of regulation of pharmaceuticals and homeopathic products.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @11:57PM
If someones decides to shop in the quack aisle of the drug store, that's their responsibility. My wife happens to have a thing for Chinese medicine and sometimes buys those kinds of herbs, which are also unregulated. It's not my thing, but the 2015 Nobel Prize for medicine [nih.gov] recognized a malaria drug based on traditional Chinese herbs. Western medicine, despite its many success, doesn't have a monopoly on healing and often fails. People should have the freedom to explore alternatives.
(Score: 2) by sjames on Thursday February 02 2017, @01:40AM
All they had to do was post actual tests or a reference to them. Death Monkey did find some actual FDA measurements posted seperately. Those do not support the theory that the tablets caused any adverse reactions.
Personally, I'm glad that the FDA is limited, mostly in the area of herbal medicine. It's all some people can afford. Would you leave them with no options (other than burglarizing a pharmacy) at all?
I don't advocate just disbanding the FDA, but I would fully support replacing it with an agency more tightly focused on actual safety and rational risk assessment.
(Score: 3, Informative) by DeathMonkey on Wednesday February 01 2017, @07:49PM
Test Results are on their website. [fda.gov]
(Score: 2) by sjames on Wednesday February 01 2017, @08:52PM
Thank you, good information.
Unfortunately, it confirms my suspicion. The biggest outlier of the lot was a single pill that contained 1.1 MICRO-gram of atropine. The dose used medically is .01-.05 mg/kg. So, definitely don't give the baby 70 pills at once. It seems unlikely that a dose of 1/70th the minimum dose used in medicine is the cause of any deaths.
It does suggest that tightening up process controls is in order but a mass recall probably is not.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @10:58PM
Maybe the ten dead babies were Muslim?
(Score: 1) by anubi on Wednesday February 01 2017, @09:57AM
This is something the "Relion group" is gonna get mixed up in.
Any day now, we will be tormented by yet another volley after volley of TV ads by their hard-as-nails blonde bombshell.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 3, Informative) by Phoenix666 on Wednesday February 01 2017, @12:34PM
I did a little checking to see if it's a case of mis-identifying herbs, since I know that there are some like water hemlock and cow parsnip that are commonly confused. It seems juice from the berries of black nightshade are used for toothache [dailykos.com], so that part makes sense. Black nightshade is native to the Americas and was safely consumed by natives before Europeans arrived. It's easily confused with deadly nightshade, though, which is probably what happened here.
It does seem like peppermint or clove oil would be a better choice with babies, since it only takes a couple berries from deadly nightshade to kill a baby, whereas it would only sicken an adult.
Washington DC delenda est.
(Score: 1) by JavaDevGuy on Wednesday February 01 2017, @04:45PM
The FDA should be telling everyone to avoid homeopathic products as they are a fraud. Even worse than economic damage people with real issues can end up taking this snake oil and can suffer serious issues from not getting effective help.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @09:35PM
The product in question wasn't "homeopathic" as there was a measurable amount of the active ingredient in the product being sold. (Actual homeopathic "remedies" rely upon "water memory" and dilution to the point where the existence of a single molecule of the active ingredient is statistically unlikely to exist in the sale product.)
As far as remedies derived from natural sources, as seems to be the case here, people tend to become quite agitated when someone threatens to ban stuff which has been in use for years - perhaps generations - to the point where in some cases the nannygov gets so flustered by the outrage it caused that it backs off from nannying [latimes.com].
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @10:53PM
The FDA won't act, but the FTC is making them put up or shut up [npr.org] on their labels.
(Score: 0) by Anonymous Coward on Wednesday February 01 2017, @11:02PM
You can't ban water, idiot.
(Score: 0) by Anonymous Coward on Thursday February 02 2017, @05:28AM
Trump should make him (if it's a man) head of the FDA.
(Score: 0) by Anonymous Coward on Thursday February 02 2017, @06:46AM
...say hello to Hylandcare.