SoylentNews is people
SoylentNews
When they're not potentially infectious, they have extraordinary health claims.
The maker of wide-ranging "water-based homeopathic medicines" has recalled 32 products marketed to children and infants due to microbial contamination, according to an announcement posted on the Food and Drug Administration's website this week.
The announcement does not provide any specifics about the contamination or potential risks. However, the North Carolina-based manufacturer behind the recall, King Bio, issued a similar announcement back in July. At that time, the company recalled three other products after an FDA inspection found batches contaminated with the bacteria Pseudomonas brenneri, Pseudomonas fluorescens, and Burkholderia multivorans.
Pseudomonas brenneri is a bacterium recently found in natural mineral waters, and its clinical significance is murky. However, Pseudomonas fluorescens is known to be an opportunistic pathogen, causing blood infections, and Burkholderia multivorans can cause infections in people with compromised immune systems and cystic fibrosis. It was also recently found to be a rare but emerging cause of meningitis.
[...] UPDATE 8/24/2018: King Bio updated its website to include a note about the recall. The company wrote that: "Within the past two weeks, microbial contamination was discovered in two children's products, but as an added measure of caution, we chose to recall all the children's products manufactured from August 2015 to August 2018." It added that no injuries or illnesses have been reported to date.
(Score: 0, Troll) by Anonymous Coward on Monday August 27 2018, @03:10PM (38 children)
The original purpose of the FDA was to ensure the product contained what it said on the label, and nothing else in amounts above whatever acceptable levels they set. So good job, now get out of the trying to assess efficacy, or preventing people from drinking raw milk, or whatever.
(Score: 5, Informative) by ikanreed on Monday August 27 2018, @03:18PM (16 children)
Actually, the FDA has been banned by congress from regulating the efficacy and medicinal truth of homeopathic products since it's origination. You can blame one senator who owned a homeopathic products line at the turn of the century and thousands of totally apathetic representatives and senators since.
The only way the FDA was able to bust these lying fuckheads is because they also have the regulator power to chase down food poisoning. If these shysters do a half-assed job of cleaning their equipment of bacteria, they can go right back to selling medicine that does nothing. Yay.
(Score: 0) by Anonymous Coward on Monday August 27 2018, @04:06PM (6 children)
I already know you are wrong because regulating efficacy was not in the original FDA charter, there would be no reason to "ban" it..
Sorry, I have the pdf but this report seems to have been scrubbed from the internet:
1FDA Science Board, FDA Science and Mission at Risk, Report of the Subcommittee on Science and
Technology, November 2007. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20 [fda.gov]
Report%20on%20Science%20and%20Technology.pdf
Here are some more sources though:
https://www.fda.gov/AboutFDA/History/FOrgsHistory/EvolvingPowers/ucm2007256.htm [fda.gov]
https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act [wikipedia.org]
https://en.wikipedia.org/wiki/Kefauver_Harris_Amendment [wikipedia.org]
(Score: 0) by Anonymous Coward on Monday August 27 2018, @04:24PM (5 children)
Is English your 2nd language?
https://www.dictionary.com/browse/banned [dictionary.com] (to prohibit, forbid, or bar; interdict: )
Something doesn't need to be allowed in order to then be banned.
Thanks for the subsequent info though, and the question remains how do homeopathic medicines skip the efficacy test?
(Score: 0) by Anonymous Coward on Monday August 27 2018, @04:28PM (4 children)
Fine, use "banned" in your sense (anything the organization is not specifically told to do).
Then they were originally "banned" from regulating the efficacy of all drugs, whether "homeopathic" or not.
(Score: 2, Informative) by Anonymous Coward on Monday August 27 2018, @04:59PM (3 children)
(Score: 0) by Anonymous Coward on Monday August 27 2018, @06:06PM (2 children)
Yep, the FDA has suffered massive mission creep with simultaneously lack of appropriate funding increases along with people carving out their own political exceptions. It should be reverted back to 1938 or even earlier.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @02:43AM (1 child)
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @10:50AM
Before 1938 is before NHST.
(Score: 2) by jelizondo on Monday August 27 2018, @05:36PM (8 children)
You have to realize that the law holds two different points of view: a) as a citizen you are allowed to do anything that is not forbidden by law; and b) as a government entity you are only allowed to do whatever the law says. Sometimes this distinction causes confusion because people are not really aware that government can only do that which is specifically allowed by the law.
If the FDA was not specifically allowed to regulate the effectiveness of medicines in general, it could not do it, because it would mean overstepping its authority.
(Score: 4, Insightful) by ikanreed on Monday August 27 2018, @05:43PM (7 children)
Yes, and that law exists with a specific exception for garbage do-nothing fake medicine.
This seems like an asinine point to make. I don't think this is a technicality that anyone fails to recognize. But also you're wrong, because execution of law is a slippery subjective thing, and everyone knows that too, which is why we have courts.
(Score: 1, Troll) by jelizondo on Tuesday August 28 2018, @12:56AM (4 children)
Well, I was perhaps not very clear. You used the verb “banned” incorrectly; government is not “banned” from doing something, citizens are. If the law that establishes an agency, in this case the FDA, does not explicitly allows it to do something, then it can’t. No “banning” necessary.
Now, go read the 1906 Food and Drugs Act [procon.org] and see that the FDA had authority to regulate Homeopathic products because they were part of the law (Sec. 6) “That the term "drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals.” I highlighted the relevant portion for you.
The act was changed in 1938 (go read it [house.gov]) and in Sec. 501 paragraph (b), the law clearly states “Whenever a drug is recognized in both the United States Pharmacopeia and the Homeopathic Pharmacopeia of the United States it shall be subject to the requirements of the United States Pharmacopeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopeia of the United States and not to those of the United States Pharmacopeia.”
So you see, the FDA can and does regulate homeopathic products. And yes, I happen to be a lawyer.
(Score: 2) by ikanreed on Tuesday August 28 2018, @01:02AM
Yeah, I can tell you're a lawyer, as you're chasing a trivial technicality and irrelevant distinctions about the word choice I made as if ikanreed's posts are a body legal. Well either a lawyer or any person having an argument on the internet.
"The provisions for Homeopathic Pharmacopeia" are, to say the least, dramatically laxer. than anything we associate with drug review.
(Score: 2) by AthanasiusKircher on Tuesday August 28 2018, @02:13AM (2 children)
Geez. Don't be an ass.
Look, the FDA itself has traced the history [fda.gov] of this. Read the "background" section near the beginning of that document.
There you will find that: (1) the bill's senatorial sponsor in 1938 was a homeopathic doctor who sought to create a separate category of drugs under the FDA subject to different regulation, (2) due to technicalities about the wording, the FDA can't regulate many "homeopathic" drugs in the same way it does other drugs, and (3) the FDA has not reviewed or approved any homeopathic drugs under normal OTC drug review partly because -- in the FDA's own words -- "the Agency categorized these products as a separate category and deferred consideration of them."
So no, you're technically right that the FDA wasn't "banned" from regulating them. It was merely forced to recategorize them in such a way that they've historically been subject to basically no regulation.
Which is... Kinda sorta like "banning" them from their normal regulatory practices in all but the most legalistic sense.
You may be a lawyer but that doesn't abrogate your responsibility to present the facts and situation fairly.
(Score: 2, Troll) by jelizondo on Tuesday August 28 2018, @04:39AM (1 child)
Comes with the territory...
A technicality will get you out of jail...
I'm not a reporter, pal; I don't have a resposibility to present anything fairly. I present my side of the case, your lawyer presents your side, the jury decides.
(Score: 2) by AthanasiusKircher on Tuesday August 28 2018, @10:42AM
No, you're not a reporter, but I assume you are still a HUMAN BEING.
This is NOT a law forum or a courtroom -- so I was talking about abrogating your responsibilities as a rational human being. (But then again, you admitted you are a lawyer, so I guess that should be expected. Though I do have some friends who are both lawyers and rational human beings. It can happen.)
My goal (and the goal of rational human beings) is to come to a fair and nuanced understanding of the situation. You're trying to win an argument at all costs, regardless of whether it involves misrepresentation or incomplete facts. No one's on trial here.
All you've told me in this exchange is that I will never trust your opinion (legal or otherwise) on this forum again, because you've just admitted you don't give a crap about presenting things in a fair and truthful manner.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @01:27AM (1 child)
You see it all the time, with people arguing that you don't have the right to do X because the Constitution doesn't explicitly mention such a right.
(Score: 2) by requerdanos on Tuesday August 28 2018, @11:54AM
To be fair, this is simply a factually inaccurate misstatement of the tenth amendment: "The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."
It means roughly that the Federal government doesn't have the authority over X because the constitution doesn't explicitly mention such authority.
I suppose you could argue that the FDA, as part of the Federal government, doesn't have any but extremely limited, specifically enumerated power, but that kind of argument (while not outright unreasonable) usually dies when challenged in court, these things being interpreted rather more and more broadly with time.
(Score: 4, Insightful) by Thexalon on Monday August 27 2018, @04:07PM (20 children)
Why shouldn't the FDA try to ensure that the products being sold for medical purposes are actually effective at doing what they say they do? That would seem to be kinda important.
And if you don't understand why, consider this: Medicine A is FDA-approved. Medicine B is FDA-approved. Because the FDA is no longer assessing efficacy, you and your doctor now have no idea how effective Medicine A and Medicine B are going to be at fixing whatever your problem is. Now, you can ask the manufacturers for data, but their response will invariable amount to "Oh sure! Of course our medicine will totally fix your problem! Guaranteed!* * not actually guaranteed at all, but you can't sue us, so nya nya nya!" and thus is completely useless for figuring this out. You can go to the non-FDA literature on the subject, but the manufacturers of both Medicine A and B have both funded numerous scientific-looking studies published in prestigious-looking journals that your doctor doesn't have time to read and evaluate that show that their products cure everything imaginable, so that doesn't help either.
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 Monday August 27 2018, @04:24PM (19 children)
Because they suck at it.
(Score: 1, Insightful) by Anonymous Coward on Monday August 27 2018, @05:15PM (1 child)
Corporate/capitalist "science" sucks at it even more.
(Score: 1, Insightful) by Anonymous Coward on Monday August 27 2018, @06:03PM
Who said they didnt? The entire healthcare industry is overrun by scammers and their useful idiots.
(Score: 3, Informative) by Thexalon on Monday August 27 2018, @05:42PM (16 children)
1. What enabled you to determine that they suck at it?
2. What alternative do you propose that would not suck at it? I mentioned a couple of alternatives and why they wouldn't work.
3. Is there a reform to what the FDA is doing to test efficacy that would make it not suck?
Because without an answer to any of those questions, I'm going to assume that what you really mean is either "The FDA is an arm of the government, the government always sucks, ergo the FDA sucks, QED" or "I've read something somewhere that may well be written or funded by someone who is trying to get FDA approval for something highly questionable and is mad that they haven't gotten that approval". Neither of those should be taken seriously.
The only thing that stops a bad guy with a compiler is a good guy with a compiler.
(Score: 4, Insightful) by ikanreed on Monday August 27 2018, @05:46PM (15 children)
Going back to the op, seems like what enabled them to determine they suck at it is a NaturalNews-esque belief that raw milk won't fucking kill one out of twenty of the people who drink it.
mm mm enterotoxigenic ecoli goodness.
(Score: 3, Informative) by Thexalon on Monday August 27 2018, @05:59PM
I've had raw milk and didn't die, but I had it in an environment where I had been involved in feeding and milking the cow and was thus reasonably certain that the cow was quite healthy and we were taking appropriate precautions against infection throughout the process (e.g. making sure her teats were clean and sanitized before milking). Also, legalizing sale of raw milk from your buddy the dairy farmer down the road is also an entirely different animal (so to speak) than legalizing raw milk in supermarkets where you have absolutely zero idea what the supply chain looks like, and guess which of those these kinds of fools are really keen to legalize?
The only thing that stops a bad guy with a compiler is a good guy with a compiler.
(Score: -1, Troll) by Anonymous Coward on Monday August 27 2018, @06:00PM (13 children)
Nope, its just that they use NHST, which is straight up pseudoscience. They disprove a null hypothesis and then conclude that their (other) hypothesis is correct.
(Score: 3, Interesting) by ikanreed on Monday August 27 2018, @06:10PM (12 children)
Bayesian true believers up in the house, who have no way to decide if something is actually true, but they still think you're wrong about everything somehow.
Either that or you think drug companies aren't required to submit massive dossiers establishing the underlying mechanisms by which they think experimental drugs work.
(Score: 0) by Anonymous Coward on Monday August 27 2018, @06:20PM (11 children)
NHST vs (correct) science is orthogonal to frequentist vs fisher vs bayesian. You can calculate values for one hypothesis and (incorrectly) apply them to the one you actually care about using any method.
They do submit this. It amounts to stringing together a bunch of NHST results. It wouldn't matter so much (just be a waste of time/money) but when are they required to make some precise numerical prediction about future results to demonstrate they understand whats going on? Never.
(Score: 2) by ikanreed on Monday August 27 2018, @06:50PM (10 children)
Ah, now I see what you're getting at. But the reality is that real world medical data is super messy, and interfered with by a billion things that no model could accurately handle. You're asking for an exact windspeed of a hurricane when it makes landfall based on the tropical depression forming off the coast of West Africa. Working on a clinical trial is more about the 90% probability arc for 6 days. And making sure people don't die. If with the multitudes of data we have on storm tracks and a very reliable understanding of the underlying mechanisms, the real world doesn't allow for that kind of precision.
And finding reliable dose-response curves are often a goal of secondary trials.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @10:52AM (9 children)
Science is just too hard so we use pseudoscience instead! Yep
(Score: 2) by ikanreed on Tuesday August 28 2018, @02:01PM (8 children)
There's nothing unscientific about the hypothesis "we expect to see improved results in this specific area and if we don't compared to a placebo (or standard treatment)". Sorry you're enough of a pseudoscientist to reject controlled experimentation that doesn't fit your engineering-broken brain.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @05:30PM (7 children)
This isnt even close to being an hypothesis. Im guessing there are typos in there though. A hypothesis would be something like "this drug causes nitric oxide release from endothelial cells which leads to arterial dilation which leads to lower arterial pressure if there is no concomitant increase in blood pressure".
Then you'd have to build a quantitative model of
This model can be entirely empirical if you want (eg use machine learning), but once the function is chosen and all the "best" parameters/coefficients are picked someone needs to collect new data from new people/rats/whatever and show that it still works, because you did (without a doubt) overfit to the data used to develop the model.
Go find me a clinical trial that includes something like this or cites it as supporting evidence. You wont find any... It doesnt exist.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @05:31PM
Typo:
"this drug causes nitric oxide release from endothelial cells which leads to arterial dilation which leads to lower arterial pressure if there is no concomitant increase in blood volume"
(Score: 2) by ikanreed on Tuesday August 28 2018, @07:37PM (5 children)
Your quantitative model is so damn reductionist. No way things like "how much water I drank today" factored into your gross simplifications.
No factoring in "what food did they take with the medicine affecting release rate"
No "did they exercise raising blood circulation"
No "does their case of this illness come in a more virulent strain sometimes"
No "how do their hormone levels fluctuate"
It doesn't exist because what you want is stupid, and your stupid with them.
You're a goddamn pseudoscientist.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @09:13PM
The stuff you dont account for is included in the uncertainties. That is why a model is always going to be consistent with a range of values. This is the entire point of statistics...
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @09:21PM (3 children)
Anyway, this why all the talent is fleeing academia. Its filled with people who find science too hard... almost all your time is wasted explaining the most basic stuff to them. Its irritating as hell.
(Score: 2) by ikanreed on Tuesday August 28 2018, @09:27PM (2 children)
You know, for all my interactions with PhDs, I don't think I've ever met one who "fled academia" because "science is too hard"
Pointless budget cuts? Oh yeah. Tenure track becoming impossible? For sure. Noxious department politics? Definetly
Having some entirely fantastical notion of rigor that wasn't being lived up to? Never.
(Score: 0) by Anonymous Coward on Tuesday August 28 2018, @10:13PM (1 child)
You misread. Those are the ones who stay in academia... The people who dont want to put up with them (and all the BS they try to substitute for doing a good job) are the ones fleeing.
(Score: 2) by ikanreed on Wednesday August 29 2018, @01:25AM
Nah, I read you right the first time, but typed wrong. I mean you'll just have to take my word on that, and the context clues of the rest of my post.