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Homeopathic medicines make up a multi-billion dollar industry in the United States. Despite being included in the Food, Drug and Cosmetic Act, the Food and Drug Administration (FDA) has never enforced the requirement that the homeopathic industry demonstrate safety or efficacy of its products prior to putting them on the market. Although drug regulation falls within the purview of the FDA, labeling the products is regulated by the Federal Trade Commission (FTC).
In 2015 both the FDA and FTC announced workshops to review how over the counter (OTC) homeopathic products are marketed. Both agencies have the authority to increase the regulation and labeling requirements for these products. The reviews generated thousands of public comments, and the FTC is the first to release their decision in a Staff Report and an Enforcement Policy Statement.
In summary, there is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products. Accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence. Nevertheless, truthful, nonmisleading, effective disclosure of the basis for an efficacy claim may be possible. The approach outlined in this Policy Statement is therefore consistent with the First Amendment, and neither limits consumer access to OTC homeopathic products nor conflicts with the FDA's regulatory scheme. It would allow a marketer to include an indication for use that is not supported by scientific evidence so long as the marketer effectively communicates the limited basis for the claim in the manner discussed above.
Essentially, any homeopathic product that isn't backed up by competent and reliable scientific evidence must communicate on its label that:
- there is no scientific evidence that the product works
- the product's claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
Though largely seen as a win for consumer awareness, Slate notes the potential for this to backfire by noting that those who seek out homeopathic medicine will only have their resolve strengthened by seeing a statement pointing out that the contents of the bottle they are holding are not endorsed by the scientific community.
(Score: 2, Interesting) by Runaway1956 on Sunday November 27 2016, @02:14PM
Bone spurs. My foot started hurting at work, and I looked for a thorn or splinter in my sock. Couldn't find anything, and my foot just got worse over the next few days. Finally went to see a doctor, and he wanted a couple thousand dollars to remove the bone spur. I told him I'd let him know.
Came home, got on the internet, and started searching for homeopathic cures for bone spurs. Talked to a health food owner, talked to all the old folks in my life. Settled on a course of vitamins and minerals - primarily megadoses of calcium and magnesium. The theory seemed to be, there wasn't to much calcium in the body, but some of that calcium was in the wrong form, and not entirely soluble. So - add more calcim, and the magnesium is supposed to make calcium more soluble in water.
Science can say what it wants to say, but empirical evidence seems to have convinced the homeopathic community that this is the way to treat bone spurs.
My foot hurt for another ten days or so, but it hurt a little less each day. I never did pay that doctor thousands of dollars to cut my foot open, and put me out of work for weeks. In fact, I didn't miss a single day of work.
It would be great if all homeopathic cures could be quantified, and qualified, and all brought together into a single resource for people to find. Yeah, I understand that what worked for Great Grandma might not work for me, and what worked for me may not work for you. But, at least SOME of those homeopathic cures work, at least part of the time.
I have nothing against putting warnings on these cures. I got warnings from various sources, after all. Megadosage of magnesium are supposed to be bad for you, and I took full responsibility for any ill effects it might have on me. And, I took that responsibility.
BTW - don't even try that placebo effect on me for my bone spurs. Placebos can't erase the evidence of an X-ray. I had two spurs, one very clearly visible, the other very small and apparently just starting to grow.
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @02:33PM
So you are still taking all of that stuff?
Otherwise what's stopping the spurs from growing again?
(Score: 1, Insightful) by Anonymous Coward on Sunday November 27 2016, @03:21PM
Placebos in large doses.
(Score: 2) by Runaway1956 on Sunday November 27 2016, @05:29PM
The spurs are gone. They dissolved. No, it's not a lifetime thing, taking those megadoses. Unlike the various drugs that the pharmaceuticals give you.
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @08:07PM
What caused them in the first place?
(Score: 1, Offtopic) by Runaway1956 on Sunday November 27 2016, @08:46PM
I don't know, really. I read and heard a few things about chemical imbalance in the body, but I didn't chase very far after explanations.
http://www.emedicinehealth.com/bone_spurs/article_em.htm [emedicinehealth.com]
emedicine makes no mention of chemical balances, instead, suggesting physical problems with how the bone(s) function. Stress or rubbing of the bones probably counts for something, but a lot of people who are stressed and work hard don't develop spurs.
It's possible that genetics plays a part in it. My mother had bone spurs several times. Each time, she dealt with the pain up to a point, then had surgery. She would be off of her feet for a couple of weeks, then just hobble around the house very carefully for another two or three weeks. Around week six to eight, she would be getting out of the house, and playing catch-up with all her friends.
(Score: 2) by darkfeline on Monday November 28 2016, @08:54AM
Or it could be that the spurs went away for entirely unrelated reasons. The scientific method exists for a reason.
Given any treatment, it will work effectively for some proportion of the population, for any disease, even if that treatment is closing one eye and dancing on top of a teddy bear while tying your shoelaces. It's plain statistics.
Join the SDF Public Access UNIX System today!
(Score: 5, Informative) by EvilSS on Sunday November 27 2016, @02:44PM
Settled on a course of vitamins and minerals - primarily megadoses of calcium and magnesium.
That's cool and all, but that is not homeopathy [merriam-webster.com]. Actually, it's kind of the exact opposite of it. Many people just think it just means "natural". It doesn't. It's a specific branch of "alternative medicine" and it's a giant scam to sell really expensive bottles of water.
(Score: 2, Informative) by Francis on Sunday November 27 2016, @04:15PM
People forget just how many medicines we get from natural sources. Most of the antibiotics created during the 20th century are natural molecules that were then synthesized in a lab for industrial scale. Taxol was discovered in Yue trees and has since been used for cancer treatment. And obviously, the most famous medication from a natural source would be penicillin.
Magnesium being used for bone spurs shouldn't be that surprising as one of the things that magnesium does is regulate the calcium levels in the blood stream.
That being said, it can be a bit of a fine line sometimes between effective treatment and placebo.
(Score: 2) by Whoever on Sunday November 27 2016, @04:21PM
Or Aspirin (sort of).
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @06:46PM
And obviously, the most famous medication from a natural source would be penicillin.
Or Aspirin (sort of).
Not to mention the tears of the poppy.
(Score: 4, Informative) by theluggage on Sunday November 27 2016, @05:16PM
People forget just how many medicines we get from natural sources.
You're falling right into the FUD trap: Homeopathy is not about herbalism or natural remedies.
Homeopathic medicines are based on the theory that you can create a cure for a disease by taking a substance that causes the symptoms and diluting it again and again until there probably isn't a single molecule of the original substance left*. This avoids the embarrassing danger of the medicine poisoning the patient, leaving the field open for confirmation bias, placebo effect and regression to the mean to "prove" its effectiveness. Homeopathic medicines from honest suppliers will have been through the dilution and shaking malarkey, but since the end result is indistinguishable from sugar pills go figure how many suppliers have spotted the obvious shortcut.
Other natural remedies may be a crapshoot because of the lack of clinical trials, but at least the content of the pills can be verified and you can apply the common sense "don't take anything that you wouldn't put in your dinner anyway" approach. (Years ago, my mother started eating somethingorother leaves because she's heard "some scientific evidence" that they cured migraine... until I came across "some other scientific evidence" that they were probably causing the mouth ulcers that she was complaining about... this is the sort of stuff that the drugs industry is supposed to sort out).
(* obviously the Atlanteans/astronaut Gods did a sloppy job when they taught the ancients about vaccines and immune system disorders... [Joke])
(Score: 5, Funny) by purple_cobra on Sunday November 27 2016, @06:12PM
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @07:48PM
Oh Touche. My sides were nearly split. Wonder if I can drink a diluted joke to fix that.
(Score: 0) by Anonymous Coward on Monday November 28 2016, @11:15AM
Of course they won't accept it. A credit card isn't real money. Dip a bit of gold in the water and they should happily accept it!
And don't draw wrong conclusions when they at first reject it. You know, it first has to get worse before it gets better, so it's a perfectly normal reaction.
(Score: 2) by EvilSS on Sunday November 27 2016, @05:40PM
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @08:05PM
Taxol was discovered in Yue trees
What the F*** is a "Yue tree"?
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @11:24PM
月朳
https://en.wikipedia.org/wiki/Taxus_baccata [wikipedia.org]
(Score: 1) by Francis on Monday November 28 2016, @02:41AM
LOL, my Mandarin slipping in there. But yes, that's the tree I'm talking about. Also, it never ceases to amaze me how poor people's reading comprehension could be. Anybody that really needs to know and didn't make the connection would just look up Taxol and find that there was a typo. Everybody else would just gloss over it as the tree that Taxol comes from.
(Score: 0) by Anonymous Coward on Monday November 28 2016, @04:31AM
So, you meant a "You" tree? C'mon, Francis! You know this place is mostly Americans, so asking them to google mandarin is just like asking them to blow Eth. How much easier would it be if you checked on correct spelling? This was not even a typo. And, you are hijacking the thread, which is not at all about nature, it is about dilution and how stupid people with bone spurs can be. Besides, you left out foxglove, Datura, psylosybin, yage, and maggots.
(Score: 2) by driverless on Monday November 28 2016, @12:39AM
You also need to understand the history of medicine to see why homeopathy was initially popular. At the time, treatment was split between allopaths and homeopaths. The allopaths believed in aggressive treatment of sickness, which involved things like mercury, bloodletting (without any sterilisation or other precautions, the essence of a good solid stink in a hospital drove away bad spirits), arsenic, and other stuff. The homeopaths believed in homeopathy. Since this killed less people than what the allopaths were doing, and some of those eventually recovered, homeopathy was "seen" to "work".
Medicine has progressed a wee bit since then, but some people still believe in woo-woo + placebo. And, given that about 70% of illnesses eventually sort themselves out to some extent (which is also what makes things like faith healing work, if you're in the unlucky group where it doesn't sort itself out then it's because you didn't believe hard enough and it's your fault), it still appears to "work" in many cases.
(Score: 2) by AthanasiusKircher on Sunday November 27 2016, @04:54PM
I've always been curious about this misuse. I myself believed that the word was a synonym for "holistic medicine" or "alternative medicine" or something for several years, since it seemed EVERYONE around me used it that way. (This misconception is apparently much more widespread in the U.S. than in other places.)
I never actually believed in it myself or even paid much attention to those talking about it, which is part of the reason I suppose I didn't look into it for so long -- I just associated the term with all the various other kooky alternative medicine ideas out there. It was only after I got into an argument with a person who believed in some herbalist nonsense** that I actually started looking stuff up and discovered the distinctions. I'm guessing that the mistake has to do with the fact that most people first encounter this obscure word when talking to other kooky ill-informed people about alternative medicine, perhaps coupled with the fact that the word begins with "HOM-" and might be confused with "home remedies" (i.e., as opposed to institutionalized medicine). Related to that, I've definitely also heard it mispronounced as "Homo-pathic" on a few occasions, in contexts where the person clearly meant "homeopathy" (well, actually "holistic" or "alternative" medicine or something, but they said "homopathic").
[**Note: I'm not saying herbs can't have positive effects; obviously some do. But a lot of people who believe in herbalism also seem to believe it can do nonsensical things, as was the case in the conversation I reference.]
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @05:24PM
This is exactly the reason the FTC is changing the label. They noted that for decades homeopathic medicines have been a very small niche market, but now that it is a multi-billion industry, it is clear that people understand it to be as you did and not what it really is. This is fed by the fact that these products get shelved in pharmacies right next to traditional medicine, and they label themselves with fancy sciency-looking labels that they very much appear to be "normal" medicine. If you don't shop based upon name brand or by the drug name, you really have to read the fine print to figure out whether you are looking at a homeopathic product or a normal product, and this is done by design.
(Score: 2) by jdavidb on Monday November 28 2016, @04:00PM
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 2) by EvilSS on Monday November 28 2016, @05:04PM
Also the FDA doesn't have the authority to issue recalls on most homeopathic products. So if it was pulled, it was done at the behest of either the stores selling it, or the company that manufactured it. They can only take action after investigating and finding a clear danger with a specific product or ingredient.
(Score: 2) by jdavidb on Monday November 28 2016, @10:39PM
The only homeopathic med I know of recently pulled for infants was a teething remedy that contained very non-homeopathic levels of belladonna and was linked to over 400 hospitalizations and 10 deaths.
Yep, that's the one.
You can be assured that anything that is actually homeopathic and that isn't a cure for thirst, does not work. They are literally water with some supposed ingredient diluted down so far that the odds are there isn't a single molecule of it in the solution.
I know!
Also the FDA doesn't have the authority to issue recalls on most homeopathic products. So if it was pulled, it was done at the behest of either the stores selling it, or the company that manufactured it.
You're right - I went back and reread original announcement [hylands.com]. Basically the FDA has scared them out of the U.S. market.
They can only take action after investigating and finding a clear danger with a specific product or ingredient.
They don't feel the need to publish their data, though.
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings
(Score: 1, Insightful) by Anonymous Coward on Sunday November 27 2016, @02:44PM
(Score: 4, Insightful) by ilPapa on Sunday November 27 2016, @02:50PM
You should have tried prayer first. It's cheaper and just as effective.
You are still welcome on my lawn.
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @05:10PM
I sacrifice virgins. Works every time. The mainstream media won't tell you that.
(Score: 2, Flamebait) by SomeGuy on Sunday November 27 2016, @05:01PM
What you have demonstrated is a combination of how there is not as much science done in this world as we might think, and that doctors are all corrupt money grubbers.
Were there sufficient known science in this area then the doctor would have been able to diagnose that this treatment would have worked, or explain why it actually didn't and other stuff happened to correct the problem instead. They can not and will not do that as they always go for the most expensive treatment possible.
Actually, I'm a little surprised they didn't just prescribe some over priced "scientifically proven" medicine that doesn't do anything but make people sicker and would keep you coming back to them for the next 50 years. Must have figured they would only get the one shot, or planed a convenient "complication" in the surgery that would keep you coming back anyway.
(Score: -1, Troll) by Anonymous Coward on Sunday November 27 2016, @05:16PM
Yeah it's those damn DOCTORS trying to get you to buy things you don't need. All to make the pharma companies rich. It's all those doctors and scientists crushing the working man.
(Score: 1, Troll) by fishybell on Sunday November 27 2016, @06:42PM
Yeah! I mean, that doctor has a boat! A BOAT!
(Score: 2) by sjames on Sunday November 27 2016, @07:44PM
It's more professional negligence than deliberate corruption.
Most doctors have no idea how much a prescription or a lab test will cost the patient and they don't care. Some even try to claim it would be unethical to consider price at all. That's why they prescribe 800mg ibuprofen at $0.30/dose (online discount pharmacy) rather than tell you to take 4 generic OTC ibuprofen at $0.05/dose.
But in IT consulting, for example, just imagine you tell your consultant you have a static 4 page website you need hosted reliably and he recommends you buy 2 IBM-s390 mainframes and locate them in two locations over 500 miles apart with redundant networks. Sure, he certainly met your requirements (and how!) but is he competent? When you later find out you could have done it for under $10/month and angrily confront him, he claims he had no idea a mainframe was so expensive and that it would have been unethical for him to look at the costs!
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @08:58PM
MD here. This is far from universally the case. For the record, every time I dismiss a patient on Ibuprofen it gets changed to a multiple of the OTC 200 mg tab just as you say. At my institution, if this isn't done the pharmacist catches it and fixes it; it's a priority for us to be as gentle on the patient as possible.
Regarding test costs - in medical training the cost of tests is deliberately abstracted, because they want us to focus on obtaining the right tests in every case. Younger doctors usually feel they need more diagnostic tests, and as they get more seasoned often they are comfortable with less. Clouding the waters with test pricing, making people less apt to order the proper studies, would harm patients. Medicine is rarely black and white, and multiple problems often coexist, so despite our best efforts to standardize practice it's often impossible to sketch out a perfect path without robust testing/scanning.
That said, over time usually doctors get a sense of what they're ordering and do modify their practice accordingly. However, emergency departments will pretty much repeat everything everywhere every time, because time is precious, things can have changed, and getting outside records can take 30 days.
(Score: 2) by bzipitidoo on Sunday November 27 2016, @10:58PM
What I see is that most doctors are honest, but that the system has all kinds of features and pressures that lead to very expensive care. Time is usually chosen in a choice between saving time or money. Everyone is angling for a piece of medical action, trying to make the default knee-jerk act the one that makes them a big profit. Billing is deliberately opaque, complicated, and confusing, for no good reason. Yes, medical care is not simple, but it's not as complicated as billing tries to make out. The reason for the needless complexity is obviously so they can better hide outrageous costs.
From a financial point of view, obtaining care at a US hospital is like walking into a tar pit. I went to emergency 3 times 2 years ago for a kidney stone. Over the next year, I asked questions and argued over the sky high bill, which included such gems as 3 bags of saline solution for $306 each, which insurance reduced to $150, $64, and $27 respectively. I questioned and questioned them about why the same item had such wildly different and high prices, and neither the hospital nor the insurance could explain it. It's their business to know, and they didn't know. Insurance would adjust the price to make it $27 each all 3 times, and I'd think the matter was resolved, only to find out a month later that the flunkies in the call center had their changes reversed. They made wild guesses, like that the price reflected additional medication added to the saline solution. Wrong. All medicine was billed separately. Or maybe it was something else bundled into the price. Wrong again. Or perhaps it had to do with the day of the week, with weekends being a more expensive time. Nope, also wrong. I told them that I refused to pay a bill I didn't understand. Finally I asked someone who sells health insurance for a living to explain it, and it took him several days to figure it out. The price of all the items depends on the level of emergency care required. The level can range from 1 to 5. They rated my level as 4 on the 1st visit, 3 on the 2nd, and 1 on the 3rd.
Even though I finally had an explanation that was correct, I decided I nevertheless did not agree with the system. According to Medicare, a bag of saline solution is worth about $1.50. Even $27 is an outrageous markup. Next I tried a medical billing advocate. They helped, but not enough. They pointed out that I was being double billed for the level 4 care, as they were also charging this so-called facility fee, and at level 4, that fee is supposed to include bags of saline solution. (Medicare does not allow facility fees, sets their value at $0.) I finally realized there is no way through the maze that results in a fair price, and there were only 2 choices: pay up, or flat refuse to pay.
The US makes refusing to pay a shockingly viable option. Hospitals have signs all over the place that state they are not allowed by law to refuse care to someone for not having paid a past bill, so if you don't pay, they can't get you that way. Of course, you could still suffer a fatal accident on the operating table, and who would ever know whether that was a genuine accident or a sinister loss reduction move made to look like an accident. Then, there are all these laws that you can use to tell debt collectors to shut it and shove off. And finally, credit rating agencies recently changed their formula to put medical debt in a featherweight category of its own. Your credit rating will not be harmed as much by unpaid medical debt as by any other kind. I can only conclude that all this is a kind of backhanded recognition that medical billing is completely wacko.
That's hardly my only experience with crazy medical billing.
(Score: 2) by sjames on Monday November 28 2016, @12:50AM
Agreed, it's not universal (very little is), but if it wasn't common, there wouldn't be an 800 mg ibuprofen pill and we wouldn't see aggressive marketing of the newer more expensive drugs that rarely have an actual advantage over the drug they replace. In cases where the newer drug eliminates an annoying side effect for some patients, there would be more discussions about trade-offs with patients. and more trials of the old drug to see if it was even going to be a problem.
We pay 4 times as much per capita for healthcare as the U.K. That's not just random happenstance.
(Score: 2) by krishnoid on Sunday November 27 2016, @10:24PM
When you later find out you could have done it for under $10/month
... from one of the other competitive/comparison quotes you should have gotten at the same time, but didn't ... ?
(Score: 2) by sjames on Sunday November 27 2016, @10:45PM
So do you comparison shop for healthcare? Can any of them even quote you a price? Do you have to pay them to evaluate your condition first?
Do you have a designated proxy to do all that for you if you are incapacitated?
(Score: 2) by krishnoid on Sunday November 27 2016, @11:17PM
So do you comparison shop for healthcare? Can any of them even quote you a price? Do you have to pay them to evaluate your condition first?
The hospitals I've dealt with have dedicated departments for both quoting estimates and negotiating discounts. I guess if the costs were that high, I could consider the medical tourism route and check with what other people finally paid in similar situations.
Do you have a designated proxy to do all that for you if you are incapacitated?
Does family count?
(Score: 2) by sjames on Monday November 28 2016, @01:07AM
Doctor: He needs this treatment in the next 5 minutes or he'll die!
Krishnoid'a family member: Uhhh, I dunno, I'll call around and get back to you...
Meanwhile, I have heard of estimates from hospitals. They don't include a number of very expensive parts of the procedure in many cases.
(Score: 3, Informative) by fishybell on Sunday November 27 2016, @06:35PM
From the FTC [ftc.gov]:
Bone spurs are typically self-limiting, can be self-diagnosed (as in, before going to the doctor, and especially if you've had them before, you can think you have bone spurs), and are typically self-treated with non-steroidal anti inflammatory drugs. Self-treating with magnesium and calcium likely had no effect other than in your head. The symptoms likely would have gone away in the same amount of time with no help. Of course, you can't go back in time and not treat it, so there's no way of knowing...which is pretty much exactly why homeopathic remedies are so popular: the, "it can't hurt," and the "I think it helped me" trains of thought.
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @06:44PM
Which is why I take a prophylactic 2-4 liters of beer daily to prevent... whatever, man. It would have been worse without it, I KNOW that.
(Score: 0) by Anonymous Coward on Sunday November 27 2016, @11:33PM
[...] why homeopathic remedies are so popular: the, "it can't hurt," and the "I think it helped me" trains of thought.
The latter applies to conventional medicine.
(Score: 0) by Anonymous Coward on Monday November 28 2016, @02:51AM
When I moved from LA to NY, I had to do a lot more walking. I got bone spurs too. Excruciatingly painful. My dad raised me with a generous dose of skepticism of the medical community (he was a hospital administrator) so I didn't go to any doctors at all. I didn't take any vitamins or change my diet in any way. I just kept going until it hurt, then I'd sit down for a bit and then go again. After about ten days, they went away and never came back.
I'm sure that if I had believed in voodoo and did a little ceremony I'd be convinced that's what cured me. Instead, I'm pretty sure it was just the body taking care of itself.
Correlation vs. causation. It gets people every time.