This report from Ars Technica details an important warning from the U.S. Food and Drug Administration
from the article:
For a sinister Shakespearian brew to conjure spirits, you're going to need to gather a variety of mystical herbs, like the scale of a dragon and the cool blood of a baboon (or maybe a spotted gecko). For eternal life, harvest a dead man's toe and a newt's saliva.
But if dry eye relief is all you seek, then the urine of a human fetus is what you'll need—just don't mention it to the Food and Drug Administration.
The regulatory agency posted a public safety notification warning people not to use eye drops with such ingredients—products more akin to hocus-pocus than modern medicine.
The eye drops are thought to contain amniotic fluid, the clear liquid that surrounds and cushions a human fetus as it incubates in a womb. Generally, amniotic fluid contains a variety of maternal and fetal excretions and secretions, but after the 10th week of gestation, it is largely fetal urine, with fetal lung secretions being another significant component.
Makers of these tinkly eyedrops claim they can treat eye conditions, namely dry eyes and inflammation. Any such biologic-based product claiming to cure or treat a condition is regulated by the FDA under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. As such, these products require an investigational new drug application (an IND) to be tested in humans and a full FDA approval before hitting the market.
This appears to have been news to at least two companies that the FDA sent warning letters to late last year. The companies, Regener-Eyes [PDF] and M2 Biologics [PDF], were illegally selling unapproved eye drops, which the FDA said contained amniotic-fluid, to treat dry eyes.
In fact, there is not a single amniotic-fluid eye drop product approved by the FDA, and any such product used under an IND requires patients to sign consent forms. Yet, the FDA is finding these products on the market, the regulator said in its notification.
Wait, what? Amniotic fluid? Whether it works or not (probably not), I want to know how these companies can harvest enough to make commercial quantities of their products.
(Score: 1) by anubi on Wednesday April 26, @07:10AM (5 children)
Well, just a few minutes ago, this stuff I'm getting rid of was in my bloodstream. The same salts, the same pH. Sterile ( unless something's bad wrong with me. I would say fresh urine would better than saliva, which I suppose every mammal, including me, will use as the fluid of choice for dressing hurts.
Gotta be fresh stuff though. It is loaded with urea, an end product of protein metabolism, which will rapidly degrade to ammonia, which is why stale pet deposits and diaper pails stink so much.
I think I would prefer my own urine to amniotic fluid though. Mine already has my exact pH and salinity.
I've often wondered if Murine was artificial urine in pH and salinity ( various blood electrolytes ) sans the urea.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 2) by tangomargarine on Wednesday April 26, @04:27PM
Murine Ear Wax Removal System Drops?
They come up with the weirdest names for medications.
"Is that really true?" "I just spent the last hour telling you to think for yourself! Didn't you hear anything I said?"
(Score: 3, Interesting) by Joe Desertrat on Thursday April 27, @12:09AM (3 children)
Urine, as issued from an undiseased bladder, is sterile. I learned this in a book on big game hunting in Africa, where an incident was described where someone was hit in the face by a spitting cobra, and one of the others on the expedition pinned him down and started urinating in his eyes to wash out and negate the effects of the snake venom.
(Score: 3, Informative) by Reziac on Thursday April 27, @03:30AM (2 children)
Nope. 80% of healthy bladders contain naturally-resident bacteria. Pretty much the same species as occur on healthy skin. Meaning it shouldn't actually be a huge problem for unbroken skin or intact eye tissue, but still unlikely to be sterile. (Bunch of studies exist, first one I came to.)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3957746/ [nih.gov]
However, if you have to choose to wash out cobra venom with urine, Nile River water, or not at all, take the piss.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 2) by Freeman on Thursday April 27, @06:16PM (1 child)
Hold up, I'm pretty sure that "taking the piss" had an entirely different, non-literal meaning.
Joshua 1:9 "Be strong and of a good courage; be not afraid, neither be thou dismayed: for the Lord thy God is with thee"
(Score: 2) by Reziac on Thursday April 27, @06:25PM
Yes. :)
Just struck me as funny, given the topic.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 4, Funny) by Tork on Wednesday April 26, @07:53AM (11 children)
Oh how clever! SN has always been a lot faster to load for me than the green site, but now we’re gettin’ the dupes as early as the original article!!
Slashdolt Logic: "25 year old jokes about sharks and lasers are +5, Funny." 💩
(Score: 2) by NotSanguine on Wednesday April 26, @08:11AM (3 children)
My bad. I missed That copied that twice.
Sorry.
No, no, you're not thinking; you're just being logical. --Niels Bohr
(Score: 2) by hubie on Wednesday April 26, @11:25AM
Now fixed.
My bad too; I missed it in editing.
(Score: 2) by Tork on Wednesday April 26, @04:11PM (1 child)
Slashdolt Logic: "25 year old jokes about sharks and lasers are +5, Funny." 💩
(Score: 2, Insightful) by anubi on Thursday April 27, @12:03AM
My sin is thinking something, neglecting to type it in, then proceed to the next thought, failing to notice the omission until AFTER I hit the submit button.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 2) by DannyB on Wednesday April 26, @02:38PM (6 children)
Dupes is to insure that you don't miss it. In case you are not ensured.
How often should I have my memory checked? I used to know but...
(Score: 2) by Tork on Wednesday April 26, @07:14PM (5 children)
Slashdolt Logic: "25 year old jokes about sharks and lasers are +5, Funny." 💩
(Score: 2) by DannyB on Wednesday April 26, @07:59PM (4 children)
A scare crow won an award because he was outstanding in his field.
How often should I have my memory checked? I used to know but...
(Score: 3, Funny) by Tork on Wednesday April 26, @08:06PM
Slashdolt Logic: "25 year old jokes about sharks and lasers are +5, Funny." 💩
(Score: 2) by Gaaark on Wednesday April 26, @08:29PM (2 children)
Never in the field of cows was so much owed by so many to so few scarecrows.
:)
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 2) by DannyB on Thursday April 27, @03:19PM (1 child)
I shutter to think what an udder failure that would be.
How often should I have my memory checked? I used to know but...
(Score: 2) by Gaaark on Friday April 28, @02:17AM
The cows shall fight on the beaches, they shall fight on the landing grounds, they shall fight in the fields and in the streets, they shall fight in the hills; they shall never surrender.
if the Cow Empire and its Cowonwealth last for a thousand years, horses will still say, 'This was their finest hour.'
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 2) by Thexalon on Wednesday April 26, @10:42AM (6 children)
(rhymes with "sewage")
When people get delusions about modern medicine being untested (it's not, it goes through fairly rigorous testing before you or I ever see it) and bad and wrong about everything (it's not, if it were there would be even more malpractice lawsuits and the like), they turn to other stuff. And that leads to every would-be charlatan and con artist coming out of the woodwork to convince suckers that whatever nonsense they're able to get their hands on is the fix to all their problems.
And that's how you get people spending a lot more than they should on candles that allegedly smell like Gwyneth Paltrow's nether regions.
As for this particular problem, if none of the commercially available eye drops work, then I'd recommend checking the humidity levels in your home and making sure you are getting enough sleep, and if that doesn't do it then have a conversation with a doctor. Yes, doctor's visits often aren't free, but they're cheaper than spending whatever you have on nonsense that doesn't work.
The only thing that stops a bad guy with a compiler is a good guy with a compiler.
(Score: 2) by mcgrew on Wednesday April 26, @02:11PM
If none of the commercially available drops work, I'D SEE AN EYE DOCTOR! Amniotic fluid isn't going to clear up an infection, you need antibiotics or antivirals, and only one will work. And there may be other problems than an infection.
Carbon, The only element in the known universe to ever gain sentience
(Score: 2) by pvanhoof on Wednesday April 26, @04:48PM
A doctors visit to get a quick look at my eyes will cost me about 7 euros in my country. The rest is paid for by social security. Additionally when this doctor prescribes me eye drops, it's very likely that a) they will actually work and do something and b) social security will also pay the medicine back to me.
Nonsense that doesn't work has neither a nor b being applicable so it is indeed quite a bit more expensive.
(Score: 1) by anubi on Thursday April 27, @12:23AM (2 children)
My Grandpa told me all sorts of stories about "snake oil salesmen".
We still have them. Just call them by another name. Ads pitching drugs directly to laymen, as well as pharma representatives pitching directly to doctors.
Add in the profit motive, and my faith in the industrial-pharmaceutical complex is destroyed.
As it stands now, I have damm near zero faith in these newer drugs. It's been known for thousands of years our metabolism reacts to certain things a certain way.
Unfortunately, I won't live long enough to verify the efficacy of modern potions in the rear view mirror of time.
In my view, these potions exist for the same reason they existed in grandpa's day...
Monetizing misery.
"Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
(Score: 2) by Thexalon on Thursday April 27, @12:25PM (1 child)
You don't need to have faith in the pharmaceutical industry. You have to consider your options:
1. Do what a professional who had years of training and experience recommends, which is to use substances that went through a bunch of formal scientific studies for safety and effectiveness to get approval to be on the market, and many of them have been in use by lots of other people for many years or even decades, and if either the company or the professional lie to you you can sue them for it.
2. Do what some salesman or completely untrained friend recommends, which is to use substances or techniques that they claim totally work, even though nobody has been able to prove that they work with any kind of scientific rigor, and even if they had there's no guarantee that what they're selling you is what they say they're selling, and even if it was there's little to no controls of dosage. Oh, and it's also mostly produced by a big industry that makes tens of billions off of this stuff, and spends a bunch of this money buying politicians to reduce the chance that they'll ever have to deal with the kinds of regulations doctors and pharmaceutical companies have to follow.
3. Do nothing and hope that whatever problem you have fixes itself or isn't too annoying.
The evidence is overwhelmingly in favor of choosing #1 for anything major. Like, if you're using camomile tea at night to help you sleep, that's probably fine, because even if it doesn't work it's probably not a big deal. But if you're trying to treat, say, epilepsy, nothing's going to work as well as the pills.
The only thing that stops a bad guy with a compiler is a good guy with a compiler.
(Score: -1, Offtopic) by Anonymous Coward on Thursday April 27, @02:53PM
I choose #1 as well, but I've worked around cagey types long enough to smell a rat when they try to hide one, and what I am seeing in worldwide politics stinks to high heaven.
Bread and Circuses for the pee-ons!
I know, the easiest ways to control people is fear, greed, and ignorance, all of which I am seeing in abundance these days.
(Score: 2) by Reziac on Thursday April 27, @03:35AM
Humidity, and also chronic dry eyes are a symptom of hypothyroid. (Dry mouth too.)
Some days one wonders if quacks outnumber the rest of us.
https://quackwatch.org/ [quackwatch.org]
I consider the PDR for Herbal Medicine to be a horror novel. Lordy, just reading the known side effects....
And there is no Alkibiades to come back and save us from ourselves.
(Score: 5, Funny) by MIRV888 on Wednesday April 26, @10:49AM (11 children)
I realize this will seem tertiary to the article, but a proper education would preclude people from putting urine / fecal matter in their eyes.
(Score: 2) by Gaaark on Wednesday April 26, @11:03AM (1 child)
There's a Tit Tot challenge for you: "Hey guys/gals: today, we're NOT going to do anything stupid! Challenge!"
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 3, Funny) by Joe Desertrat on Thursday April 27, @12:11AM
It would never be popular. Too many would fail.
(Score: 0) by Anonymous Coward on Wednesday April 26, @11:14AM (1 child)
We don't need no education
We don't need no thought control
-GPinkFloydT
(Score: 4, Funny) by DannyB on Wednesday April 26, @02:39PM
Please pass a continuing resolution to retain the dark sarcasm in the classrooms.
How often should I have my memory checked? I used to know but...
(Score: 3, Interesting) by Runaway1956 on Wednesday April 26, @01:12PM (1 child)
And yet - there is a lot of current research overturning common wisdom that we shouldn't eat poop. In fact, they are not putting poop in capsules, and prescribing those capsules to people with immune problems.
I agree with you, and I'm not putting any human waste into my eyes, no matter how dry they might seem. But, I'm willing to keep an open mind that it might be beneficial for some people to put amniotic fluid in their eyes.
The real problem is, no one has done the research, no one has gone through the FDA or any other channels to have the treatment approved. They just started bottling some stuff that they claim to be amniotic fluid.
And, how much amniotic fluid is actually in their product? Maybe a pregnant woman drove past the factory last week, and they called that good enough.
Abortion is the number one killed of children in the United States.
(Score: 3, Interesting) by Reziac on Thursday April 27, @03:41AM
More likely it's amniotic fluid from slaughtered meat animals, which occasionally come up pregnant. There is no waste product so bizarre that you can't find a market for it. If there is any benefit, it's likely to be from hormonal content. But, New Age = Belief in Magic, and the less useful in normal practice, the more magical.
Some animals routinely consume poop. Rabbits need to for the nutritional value. Dogs do it regularly, with a distinct hierarchy of preference, starting with the cat box and ending with their own.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 4, Informative) by HiThere on Wednesday April 26, @01:58PM (2 children)
Fetal urine ought to be pretty safe. Urine is supposed to be sterile anyway, and a fetus hasn't been exposed to many microbes.
Now why one would think it beneficial...that's another question. But think of it as a strong solution of salts in a weakly acidic carrier.
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 2) by Osamabobama on Wednesday April 26, @05:35PM (1 child)
It reminds me of [the possible urban legend] snake urine soup. Allegedly, a snake is fed only wine for weeks, and the urine is collected to be used as the base of a soup. So a known input is processed by a biological system to get a specific output.
I think I'll stick with yeast excrement, although not for my eyes.
Appended to the end of comments you post. Max: 120 chars.
(Score: 0) by Anonymous Coward on Thursday April 27, @02:59AM
You don't say [wikipedia.org].
(Score: 4, Insightful) by mcgrew on Wednesday April 26, @02:17PM
Yes, but if people were educated, how would the billionaires steal our labor? Think of the poor billionaires!
Carbon, The only element in the known universe to ever gain sentience
(Score: 3, Insightful) by pvanhoof on Wednesday April 26, @04:53PM
I think it's just lack of mandatory social security. As this means that poor (often less educated) people wont have it. And that means that they will resort to cheap piece of shit crap like urine and other wacky nonsense for trying to DIY self-cure their painful eyes.
Here a doctors' visit will cost you about 7 euros. The medicine the doctor will prescribe to you will also be paid back. Everything else is covered by nationwide mandatory social security.