Regulating magic: The FDA considers revamping its regulation of homeopathic products

Homeopathy is quackery. It can't be repeated often enough.

Homeopathy is The One Quackery To Rule Them All. It is based on prescientific vitalism and principles so addled that one must wonder whether Samuel Hahnemann, the guy who dreamt up this medical system, was a fan of excess alcohol use, opium, marijuana, or some unholy combination of the these. Think about it. The first principle of homeopathy is the law of similars, which states that like cures like. In other words, to relieve a symptom, homeopathy tells us, you must use something that causes that symptom in healthy people. There is no science behind this "principle." It's nothing more than sympathetic magic. The second principle of homeopathy is known as the law of infinitesimals. This law states that diluting a homeopathic remedy makes it stronger. Although some of the "weaker" homeopathic remedies might contain a tiny trace of original substance, the "stronger," more highly diluted remedies typically run around 30C (or even higher), with the "C" meaning a 100-fold dilution. Thus, a 30C dilution consists of 30 serial 100-fold dilutions (always with vigorous shaking, or "succussion," during each dilution), which, taken together, result in a 10-60-fold dilution. Given that Avagadro's number is roughly 6 X 1023, which means that a typical 30C dilution is greater than 1036-fold greater than Avagadro's number. Some of the more "potent" homeopathic remedies go up to 200C and beyond.

To "explain" how something that is so physically impossible based on multiple well-established laws of chemistry and physics can "work," homeopaths retreat to massive handwaving about the "memory" of water, in which the water somehow "remembers" the properties of the substance that has been diluted out of it and transmits those healing properties somehow—it's magic!—to the patient. Never mind that whatever "memory" water has lasts on the order of a picosecond. It's so implausible as to be reasonably considered indistinguishable from impossible for all practical purposes for water to transmit a "memory" of anything from a molecule and through the GI tract in any form that the body could use. It gets even more ridiculous when you consider what sorts of things have been made into homeopathic remedies. The homeopathic flu remedy, Oscillococcinum, for example, is a 200C dilution of Anas Barbariae Hepatis et Cordis Extractum (extract of Muscovy Duck liver and heart, respectively). In terms of clinical effects, the overwhelming evidence, taken as a whole, is that homeopathic remedies to no better than placebo controls, a fact once again emphasized by a recent report from the Australian National Health and Medical Research Council. Truly, I must repeat again: Homeopathy is The One Quackery To Rule Them All.

That's why it never ceases to amaze me that homeopathic remedies are, for all intents and purposes, not regulated by the FDA in the United States. Well, it is regulated, but barely. As Scott Gavura tells us, to sell a homeopathic remedy, the manufacturer doesn't have to show that it actually works, nor are there requirements for clinical trials. Basically, thanks to a U.S. Senator who believed in homeopathy, any homeopathic remedy listed in the U.S. Homeopathic Pharmacopoeia (HPUS) is by definition a drug to the FDA. In brief, in 1938, Congress passed the Food, Drugs and Cosmetics Act, whose principle author was Senator Royal Copeland. Copeland, it turns out, was physician who practiced homeopathy. In passing the law, he managed to include all articles monographed in the HPUS in the definition of drugs within the FDCA. As Jann Bellamy puts it, the HPUS is a "source for monographs, identity, methods of manufacture, standards and controls and potency levels of homeopathic products, both prescription and OTC" and "if the product is in the HPUS, it’s legal."

It's a very bizarre situation, because the FDA is required to regulate homeopathic remedies as drugs, but at the same time it acknowledges that there is no evidence showing that homeopathy works. Indeed, the FDA recently issued a warning about homeopathic asthma inhalers. I kid you not. Homeopathic asthma inhalers. It's as though the sellers of these inhalers are trying to kill asthmatic patients.

All of this makes it very interesting, not to mention an opportunity, that the FDA appears to be considering overhauling its regulatory framework for homeopathic products. As a first step, it's holding a public hearing:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

The hearing will be two days long, taking place on April 20 and 21 at the FDA White Oak Campus in Silver Spring, MD. Registration is free and available on a first-come, first served basis, and interested parties can even request to give oral testimony. I encourage everyone who can to register and, if you're unable to register, to offer written comments. You know that Dana Ullman will be doing that, if he hasn't already registered to give pro-homeopathy testimony in front of the committee.

That being said, I have to wonder what on earth new regulation of homeopathy would look like. The FDA announcement states:

Nothing in the FD&C Act exempts drugs labeled as homeopathic from any of the requirements related to approval, adulteration, and misbranding, including labeling requirements. If a drug labeled as homeopathic is a new drug under the FD&C Act, it is subject to the same premarket approval requirements and the same standards for safety and efficacy as all new drugs. A new drug is defined, in part, as any drug that is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof. See section 201(p) of the FD&C Act).

So, in other words, if someone thinks up a new homeopathic remedy that's not already in the HPUS, it's a new drug and needs to go through all the testing and clinical trials that any other new drug has go through to win FDA approval. Otherwise, anything in the HPUS goes, and the FDA can only regulate homeopathic preparations for purity and to make sure they contain what the HPUS says they should contain. In any case, here is what the FDA is looking for:

FDA is seeking broad public input on the current enforcement policies related to drug products labeled as homeopathic in an effort to better promote and protect the public health. 7 FDA has developed a list of questions to facilitate a more productive discussion at the public hearing. This list is not intended to be exclusive, and FDA encourages comments on other matters related to the development and regulation of drug and biological products labeled as homeopathic. Issues that are of specific interest to the Agency include the following:

  • What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
  • What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
  • Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
  • Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
  • Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?
  • A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
  • Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such 8 products, including their indications for use, are appropriate for marketing as an OTC drug?
  • Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?

Of course, ideally, homeopathic products should be regulated as drugs without reference to the HPUS; i.e., just like any other drug. Since the FDA requires evidence of safety and efficacy before it will approve a drug, homeopathic remedies would fail that test, given that homeopathy is The One Quackery To Rule Them All (sorry, couldn't resist), and no longer be legal to market. I doubt that will happen, given the long history of homeopathy since the 1930s the large market for homeopathic products out there, and, more importantly, the law. As long as the law is what it currently is, there really isn't a hell of a lot the FDA can do other than try to regulate the purity of homeopathic remedies and crack down on the more egregious health claims made by sellers of homeopathic products.

Still, that would be a start, given that the current Congress is highly unlikely to amend the law to give the FDA more regulatory power and responsibility.

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It is galling that this worthless crap is enriching so many for zero benefit.

The key (in my limited experience) is the personal attention the practitioners provide to the credulous. The initial visit can be an hour or more. The 'assignments' include logging by the patient which records food, aches, exercise, moods, etc. Then the homeopath pretends to use those logs to design a treatment which is placebo at best, fraud at worst.

The initial sugar pills are upwards of several hundred dollars and as a bonus, the homeopath may also empower the mark to self diagnose so that subsequent pill requirements continue to enrich the fraud.

Truly disgusting waste of money time and spirit.

the FDA can only regulate homeopathic preparations for purity and to make sure they contain what the HPUS says they should contain

IANAL, but does this mean that the FDA could block the sale of homeopathic remedies when the claimed dilution is at least 12C and it contains detectable amounts of the substance that's being diluted? Obviously there is an acceptable threshold for random impurities--there are limits to how pure you can make anything, both legitimate drugs and homeopathic remedies. But if the label specifically states that you should expect to find one molecule or less of the alleged active ingredient, and you find measurable amounts of said ingredient, isn't the product mislabeled?

By Eric Lund (not verified) on 27 Mar 2015 #permalink

the FDA can only regulate homeopathic preparations for purity and to make sure they contain what the HPUS says they should contain

How on earth can anyone, including the FDA, make sure that homeopathic remedies contain what the HPUD says they should contain? Is there an objective way to test the "memory" of water?

OT: wrt my location, sitting at my dad's bedside, observing the carefully non-reactive expression on the faces of ostensibly science-based practitioners when they suggest a woo-based, alternative treatment for which there is really no good evidence, and someone *koff* mentions this.

Regarding homeopathy, the US Senate wrote the strongest regulations possible: They started with real regulation, and then watered it down until nothing was left.

If the products were subjected to trials that are as stringent and time consuming and costly as trials for real medicines, well, have at it, FDA.

Wouldn't there be inconvenient and consumer faith-shaking recalls for product that's exposed as useless (efficacy) water (purity)?

I do think the industry's PR clean up efforts could be entertaining, though.

I am curious given MikeMa's comment above how much of homeopathic business is driven by actual visits to homeopaths. I am more inclined to picture people buying off the shelf at the local store. One of my pet peeves is the intermingling of homeopathy and real OTC medicines on store shelves. How are consumers supposed to tell the difference between similarly packaged homeopathic pills and real medicines? (The best way I can find is that the sugar pills inexplicably cost twice as much). Based on a post this week at science based medicine, Target even has its own store brand of magic sugar pills.

Homeopathy has been a topic of discussion in my household in recent years, after a relative (not one from my bloodline, fortunately) became a practitioner of it. This person went to India to find herself, and afterwards decided to become a homeopathist.
As the representative scientist in my family (I do biomedical research for a pharma company, therefore I am the family big pharma shill), I often get asked about homeopathy a lot now.

Best quote from my homeopathist relative: "It works by means that cannot be measured."
Sigh.

Anyway, my impression is that homeopathy is actually more popular outside the US than it is here.
Does that fit with other's experience?

This person went to India to find herself

Did she meet herself at the airport, of did she need to search the countryside?

I thought I found myself in the bathroom this morning, but it was just a mirror.

By Mephistopheles… (not verified) on 27 Mar 2015 #permalink

There was some comedian (whose name I've forgotten) who suggested once that homeopathy should be regulated, by a new organisation called something like 'British Organisation for the Guarantee of Uniform Standards' and that all homeopathic products should be required to display it's initials in large, predominant letters on all packaging. I could support that type of regulation....

So, the FDA is responsible for making sure that Homeopathic remedies have "nothing" in them, right? (I mean, the point of having the FDA with that authority)

Isn't that the point of homeopathy?

I am more inclined to picture people buying off the shelf at the local store. One of my pet peeves is the intermingling of homeopathy and real OTC medicines on store shelves.

Yeah, that's what happened to me. Given that it's unlikely that we will ban homeopathy (money talks in politics), I'd like to see a clear package labeling requirement.

I think it was over at Slate that the primary apologist for homeopathy, Dana Ullman, called out esteemed host a "madman".

Which, considering the source, is a high honor. Not to mention high comedy.

By palindrom (not verified) on 27 Mar 2015 #permalink

I bet the amount of homeopathic medicine sold in pharmacies for young children with colds is quite high. There are no OTC medications approved for young children. So parents will grab the homeopathic stuff, thinking at least it is something and might work.

How are consumers supposed to tell the difference between similarly packaged homeopathic pills and real medicines?

In the US, drugs are supposed to be labeled with the active ingredient(s) therein, the amount thereof per dose, and what it is (they are) supposed to do. Taking a quick look at all of the (non-homeopathic) OTC medications I have, I see such a label on every one of them. For instance, the cough suppressant contains "Dextromethorphan HBr, USP 10 mg … Cough suppressant / Gualfenesin, USP 100 mg … Expectorant / Phenylephrine HCL, USP 5 mg … Nasal decongestant" as its active ingredients (each dose is 5 ml of liquid). Likewise, the aspirin is marked "Aspirin 325 mg (NSAID) … Pain reliever/fever reducer" (this one is per tablet).

I, too, have seen homeopathic remedies intermingled with real OTC drugs on at least one drugstore shelf (a Walgreen's in San Francisco--they even had store brand homeopathic remedies). I almost bought a homeopathic cough suppressant there: I was about to take it to the cash register when I noticed the words "homeopathic remedy" on the package, rather than the usual "Drug Facts" label (in which they would have had to admit that the product does not actually contain any of the alleged active ingredient). I don't know how thoroughly that's enforced, however.

I would like to give props to Rite Aid, at least the one that's located in my town. As far as I have looked, all of the OTC remedies carried therein have been non-homeopathic.

By Eric Lund (not verified) on 27 Mar 2015 #permalink

I am more inclined to picture people buying off the shelf at the local store. One of my pet peeves is the intermingling of homeopathy and real OTC medicines on store shelves.

Yeah. When we were out on the Oregon coast this winter, my brother and some of the other guys went on a fishing trip, so Jason (my brother) went to the store the evening beforehand to pick up some Dramamine. It's not quite homeopathy, but he also came back with some kind of "accupressure" bracelets that were supposed to fight nausea somehow. "They were sitting on the shelf right next to the Dramamine," he said, so I guess he figured they must actually do something.

I told him he was a dumb@$$ and we argued about it for a while - I think once people spend money on something, they have a tendency to defend it. Either that or it was just his long-standing resentment at having a little sister who's smarter than he is (despite being weird and "crazy"), especially since the one thing he's claimed to have more of than me is "common sense," which made the episode even more amusing.

I'd be interested to see actual data on how many purchases of homeopathic and other alt-med problems are basically by accident, and how much money the SCAMsters are making by this deception, but I suppose the data would be hard to gather.

Eric @13
I just went to Rite Aid online and searched for Homeopathic. They have a lot of stuff for sale. Maybe your pharmacist is just a decent person that recognizes woo for what it is.

By Jim Banghart (not verified) on 27 Mar 2015 #permalink

Could the FDA just make all homeopathic stuff require a prescription? That would make most of it go away.

Could they mandate warnings that they aren't distinguishable from placebos?

Could homeopathic asthma inhalers be placed on Schedule I on the theory that taking them instead of something that actually works is a potentially dangerous form of abuse?

Who is in charge of updating HPUS anyway? Could it be edited down to a blank piece of paper?

By justthestats (not verified) on 27 Mar 2015 #permalink

IIRC (going off memory, so this may be entirely incorrect), if something is in the HPUS, it's automatically approved for market if the maker slaps "Homeopathic" on the label, no premarket testing needed. Again, I have not gone back to the regulations to double-check this, but it's what I recall.

I would advocate that homeopathic product labeling be required to state the actual amounts of the ingredients in actual measurements (g, mg, etc.) rather than dilutions. It would allow consumers to compare apples to apples when deciding between a real medicine and the sugar pills.

@justthestats

I believe the Homeopathic Pharmacopeia Convention of the United States is the body that updates the HPUS.

One of the problems for consumers is that they may mistakenly believe that they are purchasing an actual herb or supplement that is 'milder' than OTC meds and has no side effects. Obviously, it couldn't have side effects.

Perhaps information about what homeopathic remedies really ARE would change consumer sentiment, The products' somewhat opaque ingredients panel doesn't help. Better labels?

By Denice Walter (not verified) on 27 Mar 2015 #permalink

I don't know how widespread this is, but our local homeopath reassures patients who are semi-skeptical that homeopathy is like a natural vaccine in which tiny amounts of ingredients will stimulate the immune system into action. This seems to reassure the gullible that homeopathy has a basis in science. Gahhhhhh

One of the problems for consumers is that they may mistakenly believe that they are purchasing an actual herb or supplement that is ‘milder’ than OTC meds and has no side effects.

Uh-huh. The situation is likely different for homeopathic "believers," but I think a lot of people who buy homeopathic remedies OTC don't realize how stupid homeopathy really is. I didn't realize how stupid it was until I got interested in the subject, and most rational people react with incredulity when I explain it to them. Better labeling at least should be required.

I also feel like homeopathic companies prey on the uninsured. I never actually used homeopathy myself, but I was uninsured as a young adult up until grad school. In college at some point, I self-medicated for a year or so with St. John's Wort, basically because I didn't have the insurance to go see a shrink. The shop I bought it at also had all kinds of homeopathic remedies, and a resident homeopath for consultation, if memory serves. I'm not sure if it's just luck, but it never really entered my head to try the stuff. I can imagine people in the same situation going for it, though.

Yes, Walgreens is notorious for promotioning homepathic products with their get-it-free rebate coupons. Even free, not a bargin.

There may be another reason *some* people buy this crap:
they believe in the arcane magic of PLACEBO and think of homeopathy as being a spur towards healing or balance or suchlike poppycock. Perhaps it liberates the prana/ Qi/ life essence to fulfill its destiny of wholeness.

By Denice Walter (not verified) on 27 Mar 2015 #permalink

Great article! Someone needs to hit hard these quacks and you are clearly the one to do it ORAC.

By James Henrick (not verified) on 27 Mar 2015 #permalink

I know this is going to result in all kinds of animosity, but I have to ask a question similar to what I have asked previously about naturopaths.

Can anyone give any specific (as in, a range of, or examples from states) information about things like licensing or regulation of this practice?

And what exactly are "prescription homeopathic remedies" like? Who gets to write such prescriptions? If I tell someone they should drink more water, would I be "prescribing a homeopathic remedy without a license"?

Sorry, but telling people that there are wacky ideas involved and the stuff has no effect is low-hanging fruit. Lots of fraudulent claims are made all the time and most of it is protected by the US constitution at least-- ever heard of "holy water"?

My recollection is that the homeopath did some advertising that he had been trained in India or some such bull (as if that made his water more believable). Once he did a few 'seminars' for the local woo-gullible groups, word of mouth spread quickly. His appointment book seemed quite full when the ex whet there.

As to the homeopathic label on product shelves in the chain drug stores, I see a lot of stuff labeled with an eye to marketing rather than the real water-woo. They use it as a tool to attract a market segment gullible enough to see it in a positive light rather than the negative it should be.

@zebra

This should help answer your questions regarding prescription vs. OTC: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm.

I believe that it would boil down to the condition being treated. If it is self-limiting or manageable by the patient, it's fine for OTC. If it is a more serious thing requiring supervision by a physician, then it would be prescription. For instance, a homeopathic "vaccine" would be prescription only.

Lots of fraudulent claims are made all the time and most of it is protected by the US constitution at least– ever heard of “holy water”?

Sure, holy water isn't illegal - nor do I think it should be - but it is also not recognized and regulated as a medical treatment by the FDA. There's quite a difference, as far as I can see.

#27 Todd W

Thanks. It is a non-regulatory regulation, as far as I can tell. And I checked Wikipedia, and as far as I can tell from that, there is no licensing requirement to hang up a shingle.

So the only people who would "prescribe" a homeopathic vaccine (your example) would be someone with a regular MD license, educated by our regular science-based, very expensive, medical schools, right?

To repeat my point. You guys tend to make a big deal out of something that either you don't know much about, or isn't really a significant phenomenon.

And I'm not referring to OTC medicines, treatments, supplements, cosmetics, vitamins,... that support, promote, smooth and tone, yadda yadda.... That kind of thing is just business as usual and isn't going away any time soon. Or is this blog going to overturn the free market system? Or muzzle free speech? Or constrain religion?

@zebra

Nope, a licensed homeopath could prescribe a prescription homeopathic "remedy", if such were covered under state licensing laws. It's not limited to licensed MDs.

Or is this blog going to overturn the free market system? Or muzzle free speech? Or constrain religion?

Hyperbole much?

So the only people who would “prescribe” a homeopathic vaccine (your example) would be someone with a regular MD license, educated by our regular science-based, very expensive, medical schools, right?

Um, no. This is the case in a few states, but by no means all. Naturopaths are allowed to prescribe homeopathic remedies (and all kinds of other stupid sh*t) for serious medical conditions in many states.

You guys tend to make a big deal out of something that either you don’t know much about

...

And I checked Wikipedia, and as far as I can tell from that, there is no licensing requirement to hang up a shingle.

Heh.

You guys tend to make a big deal out of something that either you don’t know much about, or isn’t really a significant phenomenon.

I read that as "I don't think that's important, so you shouldn't either."

By Mephistopheles… (not verified) on 27 Mar 2015 #permalink

To repeat my point. You guys tend to make a big deal out of something that either you don’t know much about, or isn’t really a significant phenomenon.

That's odd; to all lights, the former is your stock in trade.

Guys, I have seen signs for homeopathic doctors as well as naturopathic doctors, and I was talking specifically about the former. I see now that naturopaths are homeopaths but homeopaths are not naturopaths.

And I completely acknowledge that I can't keep any of them straight, but I would expect science-oriented types like you to be able to provide more statistics and specifics about regulatory regimes than Wikipedia-- that's why I asked.

So far it looks like OTC accounts for most of the growth of consumption of this stuff. And it isn't hyperbolic to suggest that you aren't going to get consumers to be immune to advertising that promises something for nothing.

Seriously, what exactly is your plan? Are you going to make some not-really-effective but not-really-harmful things illegal, and not others? That will be sorted out by how much money the particular groups can contribute to our government 'representatives'. Not science.

@zebra

If I tell someone they should drink more water, would I be “prescribing a homeopathic remedy without a license”?

No. But, if you were to give them what you claim is a homeopathic vaccine (or whatever other treatment that falls under prescription drug regulations) and claim that it will help them avoid becoming infected with X, then you would be practicing without a license.

I just recalled that a while back I had decided not to engage zebra anymore. Thus, proving the fallibility of human memory.

Zebra, don't bother replying to my posts; you won't have anything meaningful to contribute anyway.

I sometimes think that having an advanced degree in biochemistry is necessary for separating the real stuff from the marketing b***s*** when checking out the shelves at CVS.

However, upon further reflection, I recall that I was able to do this quite early on, because I was taught critical thinking skills by a very good chemistry teacher in high school. A doctorate in chemistry shouldn't be necessary to separate out the hype.

Elliott
I agree with the idea that advanced chemistry should not b required. I also think that as a fall back position the simple math required to debunk homeopathy is the easiest. if you dilute it that much, you have nothing left.

After I picked my jaw up from the floor (reading that there exists a homeopathic asthma inhaler was the cause of the drop) I hit Google. Certainly has me convinced. I am going to throw away my evil Western Medicine inhalers and when I start coughing, I'll go straight for the Oriental Cockroaches and Ipecac. I'm positive that will cure me. Eventually, the FDA will surely agree.

What JP said about the uninsured poor. That's how I fell into woo for way too long. Diagnosing yourself can often lead you far into magical thinking, since you aren't grounded in reality by the advice of an actual doctor with a medical degree. After a while, you don't know how far astray you've gone. It's easy either to assume you're sicker than you really are, or imagine you can cure yourself with whatever natural remedy you choose.

By LinnieMae (not verified) on 27 Mar 2015 #permalink

I am ashamed to admit that I "fell" for buying a homeopathic product for my first child called "colic calm" based on a recommendation. He had really bad colic for the first 3 months and though I knew that there is not much to be done and that it resolves itself over time, after 3 months of very little sleep, I was desperate enough to try anything. Honestly, other than separating me from my cash and staining a bunch of bibs (there was detectable levels of charcoal in it), it didn't do anything other than quiet my baby down for a minute or two because he was tasting something sweet, which he never had before. I probably should have done more research, but at the time I didn't even know what homeopathy was. I figured it was just some herbal concoction. It had the homeopathic labeling, the dilutions (3X, etc), but at the time, that didn't mean anything to me. Desperate people will try anything, especially when it "looks" legitimate and is sold near other drugs that can work. Oh well, at least I figured out how to use my brain eventually, better late than never. ;)

By Lenala Azhketh (not verified) on 27 Mar 2015 #permalink

So, in other words, if someone thinks up a new homeopathic remedy that’s not already in the HPUS, it’s a new drug and needs to go through all the testing and clinical trials that any other new drug has go through to win FDA approval.

This does not appear to be the case in practice. (Yes, "Cerebrum suis" is pig brain. Heel markets it as a D10 injectable.)

Otherwise, anything in the HPUS goes, and the FDA can only regulate homeopathic preparations for purity and to make sure they contain what the HPUS says they should contain.

Has anyone ever seen an HPUS monograph? (The "Draft HPCUS Proving Guidelines" [PDF] are pretty amusing, BTW.)

The "Technical Information Requirements" are outlined here:

h_tp://www.hpus.com/guideline-technical-info-subission-4-14.pdf.pdf (not a typo).

#41 LinnieMae,

In the USA, we still have an enormous number of uncovered individuals. Which is why, if one is really concerned for the health of the population, ranting about the tiny, tiny, fraction who might be injured by accessing the various alternatives is specious. Let's get access to the science-based system for those 30-odd millions first, and lower the costs to comport with what civilized countries spend.

I would advocate that homeopathic product labeling be required to state the actual amounts of the ingredients in actual measurements (g, mg, etc.) rather than dilutions.

I'm already looking forward to labels claiming pills to contain 10^-30 mg of whatever.

By Andreas Johansson (not verified) on 27 Mar 2015 #permalink

Zebra @46: I agree that everyone in the US should have insurance coverage so that they can see real medical professionals.

For myself (and I think many here will agree) the issue is that all of these homeopathic 'treatments' are *lies*. They cannot work. But they are being sold right there next to the actual medicine, that had to go through all the FDA trials and approval.

Let us imagine a homeopathic decongestant. Unlike a drug like Sudafed, the homeopathic treatment will do nothing for your congestion. So you still feel miserable, congested, probably not sleeping well, maybe getting an upset stomach from the post-nasal drip. So in addition to wasting money on some water or sugar pills, you've also wasted time when you could have been feeling better and been more functional.

And that is a mild instance of the lying wastefulness of homeopathy. You are probably not going to die from a stuffed up nose. But if your asthma treatment is water? That might kill you, or at least send you to the hospital. So there is real harm.

And it's all more upsetting because the FDA has been forced to put a veneer of legitimacy, of science-based medicine, over this hokum, because of some senator back in the '30's.

Yes, people should be free to choose what to buy, but the free market can only work if the consumers are informed.

By JustaTech (not verified) on 27 Mar 2015 #permalink

Better labels?

Upthread I mentioned the "Drug Facts" label that is required for all non-homeopathic medications sold in the US. If homeopathic remedies aren't already required to have a similar label, they should be. And none of this obfuscating "30C" or whatever dilution factor they use--make them say up front just how little (as in "none") of the alleged active ingredient they contain. Under current laws there is no way to prevent the true believers from buying this stuff, but at least we can take reasonable steps to insure that people don't buy it when they were intending to buy a real medication.

Admittedly, since IANAL, I don't know how these remedies stand with respect to the 1994 law (the acronym of which slips my mind) that basically prohibits the FDA from regulating supplements. If homeopathic remedies are still considered drugs as under the 1938 law, then the FDA should regulate them as such. If they were reclassified as supplements, then we go after the 1994 law (which we should anyway, but this would be one more reason to do so).

By Eric Lund (not verified) on 27 Mar 2015 #permalink

@ zebra: Except the MENTAL health and critical thinking skills in our country are harmed by the various bogus alternatives. As for physical health for example, I'm not OK with asthmatic children who rely on homeopathic inhalers to be just another "tiny, tiny fraction" who could be harmed. There are many other vulnerable populations that get thrown under the bus, as well.

By LinnieMae (not verified) on 27 Mar 2015 #permalink

I'm really amused/amazed that HPCUS has a toxicology committee. That's got to take an incredible amount of cognitive dissonance.

By justthestats (not verified) on 27 Mar 2015 #permalink

How would you rate a homeopathic remedy for glaucoma, prescribed by a chiropractor, who has no means of testing even for ocular pressure, let alone visual fields? Dangerous to the eyesight, I would think!

By Harvey Richmond (not verified) on 27 Mar 2015 #permalink

I’m already looking forward to labels claiming pills to contain 10^-30 mg of whatever.

I came across one "Oscillo" that listed "200CK (10^{-400} g)" earlier today, but I'm not finding it at the moment.

if someone thinks up a new homeopathic remedy that’s not already in the HPUS, it’s a new drug and needs to go through all the testing and clinical trials that any other new drug has go through to win FDA approval.

How does that work for a high-dilution homeopathic preparation where they are simply rebranding an existing bottle of water or alcohol or lactose pills?

By herr doktor bimler (not verified) on 27 Mar 2015 #permalink

Are you going to make some not-really-effective but not-really-harmful things illegal, and not others?

"Has not been shown to have any effect on any condition."

"The active ingredient, oscillococcus bacteria, has not been shown to exist. Influenza is caused by a virus."

"In the USA, we still have an enormous number of uncovered individuals."

Sadly, this is not the case at our local beach.

Come to think of it, given the prevailing morbid obesity rate, this is probably a good thing overall.

By Dangerous Bacon (not verified) on 27 Mar 2015 #permalink

Are you going to make some not-really-effective but not-really-harmful things illegal, and not others?

Let's see. If someone markets a product by claiming it does something when it demonstrably does no such thing - what's that called? Anyone?

By Mephistopheles… (not verified) on 27 Mar 2015 #permalink

#48 justatech,

The problem, in my relatively brief experience with this particular topic, is that there is not a scientific analysis of harms and benefits. To do that, you have to compare the particular woo treatment against realistic alternatives-- and *no* treatment is a very realistic alternative. Is there really data showing that the *vast* majority of kids ending up in the ER has *anything* to do with homeopathic treatment?

For instance, a homeopathic “vaccine” would be prescription only.

I fail to why "nosodes" are given a pass by the CPG; "[A drug or device shall be deemed to be adulterated] [i]f it consists in whole or in part of any filthy, putrid, or decomposed substance." 21 U.S.C. § 351(a)(1).

The boilerplate from FDA-FTC warning letters reads,

"Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval."

"Nosodes included in the Homeopathic Pharmacopoeia of the United States (HPUS) include: Anthracinum (Anthrax), BCG, Candida albicans, Candida parapsilosis, Colibacillinum, Hippozaeninum, Influenzinum, Lyssin, Medorrhinum, Morbillinum, Pertussinum, Proteus, Psorinum, Pyrogenium, Sinusitisinum, Staphylococcinum, Streptococcinum, Syphylinum, Tuberculinum, Tuberculinum bovinum, and Vaccinotoxinum." (h_tp://www.homeopathycenter.org/homeopathy-today/mortar-and-pestle-homeopathic…")

Note the lack of parallelism between "Sinusitisinum" (ouch), whatever the f*ck that is, and "Syphylinum."

Ah, here we go (PDF):

Sinusitisinum 12X - Detoxifier homaccord [sic] made from the mucopurulent secretions of inflamed nasal discharge.

#56 MObrien,

"Let’s see. If someone markets a product by claiming it does something when it demonstrably does no such thing – what’s that called?"

It's called "multivitamins that 'support' yadda yadda 'health'.

It's called "yearly checkups".

It's called antibiotics for a viral infection.

And so on. When you pass a law that covers all ineffective interventions, you will have made progress in convincing people that woo is woo.

Sinusitisinum 12X – Detoxifier homaccord [sic] made from the mucopurulent secretions of inflamed nasal discharge.

Oh, geez. I wonder what "Syphylinum" is made from?

When you pass a law that covers all ineffective interventions, you will have made progress in convincing people that woo is woo.

Which predictably simple-minded, blanket assertion has f*ck-all to do with the FDA's soliciting comments on the subject at hand, which necessarily encompasses CPG 400.400.

Oh! It's made from the pus from a syphilis chancre! But of course.

Is there really data showing that the *vast* majority of kids ending up in the ER has *anything* to do with homeopathic treatment?

It doesn't matter. There is already a regulatory framework. The question is how its implementation can be modified within the constraints of the FDA's limited resources, not sophomoric babbling of this sort:

Or is this blog going to overturn the free market system? Or muzzle free speech? Or constrain religion?

One might also note that you somehow pivoted from

And I’m not referring to OTC medicines, treatments, supplements, cosmetics, vitamins,… that support, promote, smooth and tone, yadda yadda….

to how its necessary to "pass a law that covers all ineffective interventions" or something, and anyway, "let’s get access to the science-based system for those 30-odd millions first."

You new modus operandi seems to be to pop up with "oh, dear oh dear, I know everybody's going be mean to me, but I don't know anything about this and would like to be informed" and then immediately proceed to demonstrate that you actually have the whole thing sorted out down to the last nut and bolt and everybody else is "making a big deal" out of something that "isn’t really a significant phenomenon" or else – mind-bogglingly – that it's because everybody else is just too gosh-darned ignorant ("something that ... you don’t know much about").

JP: Ew, gross. That can't be legal, can it?

By Politicalguineapig (not verified) on 27 Mar 2015 #permalink

Politicalguineapig, I'm going to guess you weren't around when Orac or a Minion brought up homeopathic plutonium, a few years back....

This may be beyond the scope of the FDA hearings, but I'd like to see much more attention paid to how homeopaths diagnose their patients in the first place in order to know what to "cure" them of. That's where the lunacy starts.

Of course when they sell this crap at the store, they have to market it toward a symptom or disease, so people will know what they're buying it for. But if you get suckered into consulting with them, they don't bother dealing with your symptoms because, you know, they "care for the whole person not the disease". Instead they draw out and analyze your personality and preferences, much like a zodiac reading. Then they consult their books full of bizarre descriptions of personality types to figure out what to prescribe. Those books consist of "provings", their "research" drawn from similar interviews with other people.

I was the subject of one of these provings, which my homeopath friend talked me into. They ask all kinds of questions about *anything but* what's ailing you and watch and listen to what's going on around you when you're talking. Because, you know, it's all in the vibes.

At the time, I thought "eh, what's the harm?" Now I'm recognizing it all as total witchcraft.

By LinnieMae (not verified) on 27 Mar 2015 #permalink

... seems it was Orac, under a post by that very name, in fact:

http://scienceblogs.com/insolence/2009/06/17/homeopathic-plutonium/

It's exactly as crazy as it sounds. That post is nice, too, because Orac covered the homeopathic "proving process" in some detail; I think of that process as the final of homeopathy's Three Pillars of Insanity, taken with the Laws of Similars and Infinitesimals.

The second hit for "homeopathic Plutonium" was a 2000 article in "American Homeopath," which contains a variety of strikingly bizarre statements:

During my discussions about her with a colleague, we came to a consensus that this seems like a desperate syphilitic state that requires something like a radioactive element.

But wouldn't that situation call for the syphilitic chancre extract Narad and JP mentioned? It's so confusing when quackeries are neither sane nor consistent.

Is there really data showing that the *vast* majority of kids ending up in the ER has *anything* to do with homeopathic treatment?

The problem is that they *wouldn't know* how many kids end up in the ER, for a variety of reasons related to alternative treatment. Maybe real treatment was delayed because alternative treatments were used, maybe the parent won't reveal their woo use for fear of the doctor's scorn.

When that happened to me, I didn't tell because I was embarrassed I'd taken it. Three years ago I ended up in the ER after I took a homeopathic remedy for dizziness; it had been recommended by my homeopath friend. Took it at suppertime and 3 hours later I was so dizzy I couldn't see straight. Staggered into the ER, where I spent 6 hours with full-blown vertigo and projectile dry heaves. I didn't tell the doctor what I'd taken, but now I sure wish I would have brought the bottle with me.

From what I've read since my conversion to science, it was likely it had no effect and that attack would have happened anyway. The doctor was puzzled that I was so dizzy for such long spells; they later thought it must be an ear virus--but only after they ruled out everything else through extensive testing.

My concern, though, is that maybe they're putting something in those faux meds or maybe there was some filler in it that I reacted to. Of course we wouldn't know any of these things because they're not regulated or inspected. As I'm writing this, I've decided to submit my testimony to the FDA.

By LinnieMae (not verified) on 27 Mar 2015 #permalink

Zebra, why are you here? What are you arguing? Are you simply trying to derail the thread in some passive/aggressive way? Really, the argument that because something that causes harm, only causes harm on a small scale compared to, say, smoking tobacco, or human trafficking, that our small band of skeptical activists, scientists, medical professionals and their allies should just stop educating people about it? Is that your argument? I get the same argument from Scientologists who just can't understand why I speak out against their relatively limited abuses compared to other cults and religions. You argue like a Scientologist.

By Pareidolius (not verified) on 27 Mar 2015 #permalink

I am disappointed that WorldCat is not just unable to locate the closest holding of a bound copy of the HPUS but that it seems nobody has ever even had reason to register the existence of this shadow government in a union catalog.

So, there are still far too many Americans who can't afford/get in to see a doctor. So they go to the drugstore and look for something to at least help their symptoms.

zebra's position seems to be that because some people can't afford to see a doctor, those people shouldn't be protected from what amounts to fraud by drugstore chains. That's ridiculous, given that people without health insurance are likely to be unable to afford the homeopathic crap, either. So someone who doesn't realize that "homeopathic" doesn't mean "herbal," it means "worthless" buys a homeopathic non-remedy for their cough. It doesn't work, but now they can't afford the actual medicine that might do them some good.

Pickwick: I’m going to guess you weren’t around when Orac or a Minion brought up homeopathic plutonium, a few years back….

*whimper*...

No, I don't think I was. God. Man, if a homeopath even mentioned that to me, I'd be out of the office so fast I'd leave afterimages. I don't know if I mentioned this, but I have an extreme fear of radioactive materials. I couldn't use a microwave as a kid, and still don't like x-rays.

By Politicalguineapig (not verified) on 27 Mar 2015 #permalink

PGP -- In case you didn't learn this sometime between your childhood and now -- there's nothing remotely radioactive about a microwave. When people speak of "nuking" their frozen burrito in the microwave, it is purely a figure of speech.

By palindrom (not verified) on 27 Mar 2015 #permalink

Political guinea pig. Your content on using microwaves made me giggle a little bit. They run on similar frequencies as Wi-Fi. A cheap or old microwave will cause the noise floor to be so high that it will shut down some Wi-Fi networks. Microwaves won't hurt you. They will just make you glow a little bit. Lol.

@Zebra
"Seriously, what exactly is your plan? Are you going to make some not-really-effective but not-really-harmful things illegal, and not others?"

The plan is to educate people about the fraud that is homeopathy. Seems like no admirable goal for you? Well, tough luck.

Hi, I'm a vegetarian. Is it OK for me to have a C100 preparation of Muscovy duck liver on the basis that there are actually no duck atoms in the remedy? Or are the duck memory holes themselves meaty? Thanks!

By Dave Ziemann (not verified) on 27 Mar 2015 #permalink

Cleaning out a garage the other day (autumn/fall cleaning?) I found an unopened box of a homeopathic "remedy". Since I'd never handled one previously, before it was consigned to the incinerator, I had a look at it.

There was an expiry date on the box! Admittedly the expiry date only just made it into this century, but... wtf?

How can a company that can neither measure the presence of an "active ingredient" nor the efficacy of the same "active ingredient" determine that beyond a certain date it will no longer be effective for the purpose it was marketed?

If a company has to put an expiry date on homeopathic products, but can't show efficacy in the first place, shouldn't the expiry date be identical to the date of manufacture?

#74 Vicki

"zebra’s position seems to be that because some people can’t afford to see a doctor, those people shouldn’t be protected from what amounts to fraud by drugstore chains. That’s ridiculous, given that people without health insurance are likely to be unable to afford the homeopathic crap, either. So someone who doesn’t realize that “homeopathic” doesn’t mean “herbal,” it means “worthless” buys a homeopathic non-remedy for their cough. It doesn’t work, but now they can’t afford the actual medicine that might do them some good."

Vicki thinks "herbal" is worth spending money on, but "homeopathic" isn't. Great, this is what it means to be a "defender of scientific medicine".

I repeat my point, which is not being answered.

1) If you are talking about OTC, there is a whole lot of stuff out there of little value-- and that includes vitamin supplements, which are displayed for sale with just as much implied legitimacy as anything else, perhaps more. And then there's the advertising, for just about everything, including cosmetic-type treatments that "rejuvenate your skin" or "give you healthy hair".

It's all woo, people. And you can't do anything about it because there's money to be made, and you have no evidence of harm-- personal anecdotes and speculation about what might happen are not science.

2) If you are talking about 'practitioners', then we are back to fixing the system so that the niche being invaded by naturopath? homeopath? is filled at a reasonable cost by scientifically trained individuals. If you do that, the already trivial problem reduces to irrelevancy.

#71 Why am I arguing? Because "someone is saying something wrong on the internet", and I have a better solution. Duh. Why are you arguing?

Palindrom: Well, I know that now. But as a kid, it was all one to me.

Zebra: Buddy, there's a huge difference between herbal and homeopathic medicines. Herbal medicines actually do contain active ingredients, and therefore mostly work. I'm not sold on the idea of St. John's Wort, but I take echinacea sometimes for colds and take herbal cough drops. (Mostly because they taste better.) Homeopathy has zero active ingredients. You do understand that if something is diluted to the point of being a millionth part of a whole that it might as well not be present at all, right? Then again, you are fantastically dim- a black hole's got nothing on you.

By Politicalguineapig (not verified) on 28 Mar 2015 #permalink

I'm amused by zebra's dogged adherence to whataboutism and his continued inability to grasp it is possible to be concerned about more than one problem at a time.

As for homeopathic provings, my favorite is that of the light of Venus.

By Krebiozen (not verified) on 28 Mar 2015 #permalink

Almost forgot.

you have no evidence of harm

Yes we do.

By Krebiozen (not verified) on 28 Mar 2015 #permalink

you have no evidence of harm– personal anecdotes and speculation about what might happen are not science

zebra, I like how you say there's an infinitesimally small number of homeopathy-related ER visits and then when you actually hear a story of one and a theory about how that happens, you immediately dismiss it as "just anecdotes."

My ER visit is related to homeopathy, at least by proximity in time. At best, I wasted my money on a remedy that was supposed to help my light, sporadic dizzy spells. This is most likely the case. At worst, there was something more hazardous in those pellets than the *nothing* that they normally contain. This has been known to happen: "Homeopathic remedies contaminated with REAL medicine get recalled". In trying to show healing results, some companies MAY be adding more ingredients than we know. Yes, this is "speculation about what might happen", as you say, but medicines that make a claim should have the burden to prove what they contain.

My written comments to the FDA would follow the lines of: My homeopath recommended that I buy this remedy. She, and the display at the store, claimed it would relieve my dizziness. Instead this is what happened. These remedies need to be inspected, regulated, and banned if they're making bogus claims.

If enough people came forward with their stories, they'd at least be forced to look at this sh*t and hopefully admit out loud that there's nothing healing about these faux meds; and there may be something dangerous about them, we don't know. The FDA is now cracking down on supplements that make health claims; they should be doing the same for even more serious woo.

By LinnieMae (not verified) on 28 Mar 2015 #permalink

#84

Krebiozen cites woo science, in the opinion of some.

http://www.ncbi.nlm.nih.gov/pubmed/23521332

How about some evidence that is available to everyone to evaluate? I have no way to know which of the two sides is making a valid point.

Zebra,

I'm so glad you mentioned those.

It’s called “multivitamins that ‘support’ yadda yadda ‘health’.

Absolutely. Any health claims by any vitamin or other supplement should be specific and backed by good science.

It’s called “yearly checkups”.

The current best recommendations say that yearly checkups are unnecessary for the majority of people.

It’s called antibiotics for a viral infection.

Everyone knows that antibiotics do no good against viruses.

I believe that all supplements and drugs should follow the same rules for approval for sale as well as for marketing and labeling. I believe the laws should be changed to ensure that all such products are regulated equally.

Of course, the difference between your examples above and homeopathic remedies (at least those above 12C dilution) is that the products provide a real benefit when used properly. A multivitamin may well be beneficial if your diet is restricted and you get insufficient nutrients from your food. While antibiotics are worthless for viral infections, they're important in curing (or sometimes preventing) bacterial infections. If you're taking medication for a chronic condition, periodic checkups are important in making sure you're tolerating the drugs well, updating the dosage, and checking the progress of your disease.

Homeopathy is based on concepts that are incompatible with current chemistry, physics, and biology. In higher dilutions (which paradoxically is claimed to provide a stronger medicine) it is demonstrable that a) there is no detectable difference between two different remedies, or between a remedy and an inert pill and b) that the odds of having even one molecule of active substance in a bottle of remedy are vanishingly small.

By Mephistopheles… (not verified) on 28 Mar 2015 #permalink

#85 Linnie Mae,

Yes, anecdote and correlation/causality fallacy are Not Science, just like homeopathy and so on. You need to decide which side you are really on.

If you want to have an FDA that provides uniform standards, and is funded sufficiently, and not subject to regulatory capture, you have my vote. So far, all I'm hearing is special interest special pleading-- regulate the other guy, not my favorite form of woo.

anecdote and correlation/causality fallacy are Not Science, just like homeopathy and so on. You need to decide which side you are really on.

There's a lot of stories out there about these unregulated woo medicines; that's what the FDA is trying to sort out. All of our stories are relevant because they can sort out what's correlation and what's causation--It's their job. And it's obvious that YOU certainly don't know. It boggles my mind that you're on the side of not regulating the safety or efficacy of stuff that makes medical claims.

So far, all I’m hearing is special interest special pleading– regulate the other guy, not my favorite form of woo.

If that's what you're hearing, then you're not reading very closely. Pretty much everyone here is saying we should regulate them all, myself included.

By LinnieMae (not verified) on 28 Mar 2015 #permalink

#88

So, we agree on uniform regulation.

Now, all you have to do is explain how ranting about homeopathy and naturopathy and so on achieves that. Again, what's the plan? We already have rules, which are easily circumvented by tricksy language in the labeling and advertising. We already have fine-print disclaimers that "this product has not been approved for treating medical conditions" or something along those lines.

We have gluten-free water, for heaven's sake.

Sorry if I don't take the histrionics here all that seriously.

Sorry if I don’t take the histrionics here all that seriously.

Project much?

By LinnieMae (not verified) on 28 Mar 2015 #permalink

#92

I am not the one claiming "I was harmed by vaccine"...oops I meant "I was harmed by GMO" ...oops I meant "I was harmed by Homeopathic water containing nothing".

Which side are you on?

The problem, in my relatively brief experience with this particular topic, is that there is not a scientific analysis of harms and benefits. To do that, you have to compare the particular woo treatment against realistic alternatives– and *no* treatment is a very realistic alternative. Is there really data showing that the *vast* majority of kids ending up in the ER has *anything* to do with homeopathic treatment?

I don't follow.

I mean, there's no data showing that being set on fire has anything to do with the *vast* majority of kids ending up in the ER.

But that doesn't mean it's arguably just as harmless as not being set on fire. Because that's just not a formula for determining harm.

Now, all you have to do is explain how ranting about homeopathy and naturopathy and so on achieves that.

These are examples of where regulation is not uniform. The law needs to be changed in order to enable uniform regulation. However, there are people who resist these changes to law. Typical reasons, as I understand it, for this resistance are:
- They benefit from the regulation system as it stands today. Someone manufacturing herbal supplements or homeopathic remedies has no particular desire to increase the burden of regulation.
- They philosophically oppose regulation in general.
- They believe that the products and services work (equivalent to or superior to science based medicine) and that any attempt to regulate is a thinly veiled attempt to remove the products and services from the market.
- They have no firm opinion but figure that the current system works "well enough".

Discussions of these topics, then, would point out the difference in regulatory environment for the different substances and services. It would point out the lack of scientific basis for claims made for these products and services. It points out the potential harms of continuing the current regulatory system. Done effectively, this could cause some people to change their minds and, eventually, to encourage their legislators to change the laws.

Thanks for asking!

By Mephistopheles… (not verified) on 28 Mar 2015 #permalink

For the record, I was never harmed by homeopathy.

By Mephistopheles… (not verified) on 28 Mar 2015 #permalink

zebra,

Krebiozen cites woo science, in the opinion of some.

In the opinion of a parapsychologist who believes in quantum woo.

How about some evidence that is available to everyone to evaluate?

The systematic review I cited is available as full text, so it is available to everyone to evaluate.

I have no way to know which of the two sides is making a valid point.

It isn't my problem that you have a habit of leaping into discussions on subjects of which you are profoundly ignorant and thus unable to evaluate.

By Krebiozen (not verified) on 28 Mar 2015 #permalink

Krebiozen @83 -- That's FABULOUS! I finally figured out how to fund my astronomical research -- not horoscopes, no, how passe, but homeopathic provings of the light of different celestial objects. And even better, the fainter the object, the stronger the effect!

My first product will be made from the light of z = 6 quasars. I may not be able to actually see them on the detector, but so much the better! Just beam the light through some water, and voila! -- enough super-concentrated BS to pay my grad students for years!

Best idea I've come across in quite some time!

[Poe disclaimer: I am not serious.]

Oh, it's even better! Rather than using expensive equipment such as spectrographs to analyze starlight, we can simply beam it through some water, give it to some subjects simply . infer the spectral properties of the light from the symptoms it induces!

I'm reserving a flight to Stockholm this minute!

#96

"These are examples of where regulation is not uniform."

*sigh*

If regulation is not uniform, everything is an example of "where regulation is not uniform".

Ranting about one particular thing is, as I said, easily seen as special-interest special pleading. I'm sure the vitamin companies would support more regulation of herbal supplements, and the herbal supplement industry would support more regulation of homeopathic concoctions, and so on. That is not "uniform regulation".

Explain what this new regulatory regime would be like. How would it change from the existing label or sales restrictions? What would prevent the product from being sold with disclaimers, as long as there was no evidence that it did harm?

"Sorry if I don’t take the histrionics here all that seriously."

Sorry, if we don't take you seriously.

If regulation is not uniform, everything is an example of “where regulation is not uniform”.

That's just plain silly. What I clearly meant is that the rules to bring homeopathic remedies to market, make claims for those remedies, produce them, and sell them are not the same as the rules for conventional drugs. The rules for someone to operate as a naturopath are not to the same as for someone operating as a physician. The rules for the production, labelling, and marketing of "supplements" are not the same as those for over the counter drugs. There are certainly other areas that could be discussed as well which require the same type of legal reform; saying that "anything" is an example is not helpful. At best it causes the discussion to diverge and dilutes the impact, making such legal reform less likely.

Ranting about one particular thing is, as I said, easily seen as special-interest special pleading.

It all depends on how the "rant" is done. If the case is made that someone else should be regulated, but not me - then that would be correct. If the case is that all should be regulated, I can't see how you can say that.

Realistically, one cannot have a blog post - no matter how long - that addresses every possible problem in the known universe.

Explain what this new regulatory regime would be like. How would it change from the existing label or sales restrictions? What would prevent the product from being sold with disclaimers, as long as there was no evidence that it did harm?

I am not a lawyer or legislator, I have no particular agenda in mind. However, I would suggest it would go something like this:
- Remove the special regulation of items on the Homœopathic Pharmacopœia of the United States.
- Require any drug, vitamin, supplement, or remedy to list the actual ingredients, as verified by chemical assay.
- Require that any drug, vitamin, supplement, or remedy that is sold to treat any condition have conclusive scientific evidence that it is safe and effective for that condition.
- Require that all drugs, vitamins, supplements, and remedies be produced with good manufacturing standards.
- Forbid the sale of any product with no detectable active ingredient and no evidence of effectiveness as medicine. The products should not be called medicine and should not be marketed in a way that appears to be medicine. They can be placed with the herbal teas or in the candy aisle as appropriate.

By Mephistopheles… (not verified) on 28 Mar 2015 #permalink

I agree that some, maybe even many, herbal medications are ineffective. That doesn't make it okay to sell people distilled water under the belief that they are getting herbal medicine. Ginger tea might help your nausea; a 30C homeopathic nostrum of any sort won't.

@PGP:

I’m not sold on the idea of St. John’s Wort, but I take echinacea sometimes for colds and take herbal cough drops. (Mostly because they taste better.)

St. John's Wort actually has some evidence behind it, though it's somewhat spotty:

Overall, the St. John's wort extracts tested in the trials were superior to placebo, similarly effective as standard antidepressants, and had fewer side effects than standard antidepressants. However, findings were more favourable to St. John's wort extracts in studies form German-speaking countries where these products have a long tradition and are often prescribed by physicians, while in studies from other countries St. John's wort extracts seemed less effective. This differences could be due to the inclusion of patients with slightly different types of depression, but it cannot be ruled out that some smaller studies from German-speaking countries were flawed and reported overoptimistic results.

I can only imagine that the placebo effect must be harder to suss out when it comes to something like depression, which can pretty much only be measured by subjective reporting. If you feel better, you are better, pretty much.

Anecdotally, I found it helpful, but a large part of that might have just been that doing something feels better than doing nothing. I definitely wouldn't recommend it to anybody over an SSRI or something, since the preparations vary widely in terms of concentration and so on, and the stuff has a lot of drug-drug interactions. Again, I was taking it because I didn't have insurance. I think I took two droppersful full of it each day, which I might have been told to, or I might have made up myself. Hey, I was like 19.

The tincture actually tasted horrible - I recall mixing it with watered-down grape juice. Those Ricola cough drops taste great, though. Sometimes I eat them when I'm not even sick.

^ Oh - echinacea actually doesn't seem to have much going for it.

A few years ago when the stories came out about so many unregulated supplements and herbals not containing what they claimed, I stopped taking any of them. I now completely avoid that aisle at my food co-op.

By LinnieMae (not verified) on 28 Mar 2015 #permalink

I'm not at all convinced by the evidence on either Echinacea or St. John's Wort - as Bausell noted in 'Snake Oil Science', the largest and best designed studies find no effect at all on depression. As we have discussed here before, St. John's Wort wasn't traditionally used for depression and Echinacea was not traditionally used to treat colds.

BTW, if you think Echinacea tastes bad, try Golden Seal. Some decades ago I had a UTI that I tried treating with the root, which tasted unbelievably awful even mixed with jam, and did nothing for the UTI (of course).

By Krebiozen (not verified) on 28 Mar 2015 #permalink

Health Canada will license a product as "safe and effective" as long as it has traditional or homeopathic use. Hardly regulating our healthcare at all. It apparently wouldn't take much for the unscrupulous or misinformed to set themselves up in business. Recently I ran into someone with a table in my local grocery store who told me several times her immune-boosting, detoxing product was licensed by Health Canada as safe and effective. I hear too often that the FDA or Health Canada are criminal or suppressing the truth, and this is the evidence that supports it. They are criminal for not requiring this industry play by open scientific rules. Wake up people, do your own research and shut down these loopholes that fail to protect our health and waste resources that could be spent on real cures.

zebra@81

1) If you are talking about OTC, there is a whole lot of stuff out there of little value– and that includes vitamin supplements, which are displayed for sale with just as much implied legitimacy as anything else, perhaps more.

RE: supplements

Cosmetics that give you healthy hair are a completely different thing. If I use Dove soap instead of Walgreens brand because it claims to give me healthy skin I may be out an extra 50 cents but that's really the only consequence. If someone buys a homeopathic inhaler which the box says can be used for mild asthma symptons that is a potentially fatal mistake. You know what mild asthma is a precursor to especially if untreated? Severe asthma. And if you wait too long to take real albuterol because you were futzing around with your water spray it's not going to help and if I need to tube you and give it inline your prognosis is far, far worse.

Sure this is all hypothetical but why allow even a hypothetical risk when there's absolutely zero benefit? Even if there have been 0 deaths it is absolutely preferrable tot bn4
The FDA is giving us an opportunity to do something about this so why shouldn't we discuss it? You are . We recognize these other problems you bring up and they are certainly important to address but they are also large, complex issues that will take time to be fixed. That's no reason to not take a minute to address other smaller problems especially when a way to do so is placed so nicely in front of you like the FDA kindly did.

2) If you are talking about ‘practitioners’, then we are back to fixing the system so that the niche being invaded by naturopath? homeopath? is filled at a reasonable cost by scientifically trained individuals. If you do that, the already trivial problem reduces to irrelevancy.

I can't recall if Orac has written about this specifically but I know the shortage of PCPs has been discussed often in the comments. I don't think anyone would deny that this is a problem, but it is an issue with our current implementation of healthcare not with the science behind it. Orac's focus has always been exposing quackery and promoting science and not so much policy reform; this particular post happens to be an intersection of the two.

@91

Now, all you have to do is explain how ranting about homeopathy and naturopathy and so on achieves that. Again, what’s the plan?

I'd suspected you hadn't read the article but this confirms it, or you are wilfully ignoring it. Orac on the FDA hearing:

Registration is free and available on a first-come, first served basis, and interested parties can even request to give oral testimony. I encourage everyone who can to register and, if you’re unable to register, to offer written comments.

@89 and 102

So far, all I’m hearing is special interest special pleading– regulate the other guy, not my favorite form of woo.

Ranting about one particular thing is, as I said, easily seen as special-interest special pleading.

The relevant topic is an FDA hearing on homeopathy. What everyone here is saying is "regulate homeopathy" because that is the issue at hand. No one has said don't regulate x, y, z, or even SBM. Orac is a rather vocal advocate for stringent regulation across the board and I suspect most his minions, myself included, agree.

By capnkrunch (not verified) on 28 Mar 2015 #permalink

If you want to have an FDA that provides uniform standards, and is funded sufficiently, and not subject to regulatory capture

Oh, the irony. The FDA's wholesale abdication of enforcement of the FDCA has led to the most complete example of regulatory capture imaginable.

Of course, that's linked in this very post, so it's understandable that you would be completely unaware of it.

One quackery to rule them all
One quackery to find them
One quackery to bring them all
And in the snake oil, bind them
Apologies to J.R.R. Tolkien for my lack of self-control. ;)

By Sheogorath (not verified) on 28 Mar 2015 #permalink

That second paragraph should read: Even if there have been 0 deaths it is absolutely preferrable to be proactive rather then reactive. The FDA is giving us an opportunity to do something about this so why shouldn't we discuss it? You are using what basically amounts to "starving kids in Africa" argument.

By capnkrunch (not verified) on 28 Mar 2015 #permalink

To add a serious comment, if there was anything to the claims made about homeopathy, then I, as somebody with non-coeliac gluten sensitivity, would suffer the same reactions from spirit vinegar that I do from malt vinegar. I never do because the gluten is left behind by the distillation process, and similarly, homeopathic 'remedies' are ineffective because there's just not enough of the original substance left to provoke any type of response.

By Sheogorath (not verified) on 28 Mar 2015 #permalink

Krebiozen cites woo science, in the opinion of some.

h[]tp://www.ncbi.nlm.nih.gov/pubmed/23521332

So you cite one of the replies, which you complain that you cannot see a bit of, and from the title you infer that Walach et al.'s "opinion" is that Posadzki et al. is "woo science"? How exactly does a systematic review become "woo science"?

Why am I arguing? Because “someone is saying something wrong on the internet”, and I have a better solution.

I'm sure the FDA will be fascinated by your input.

Duh.

Indeed.

This comment thread demonstrates nicely why I stopped bothering to engage zebra. He is impervious to reasoning and demonstrates a surprising inability to comprehend what he reads.

He is impervious to reasoning and demonstrates a surprising inability to comprehend what he reads.

Hell, he demonstrates a surprising inability to comprehend what he writes.

@Krebiozen

Have any experience or knowledge of 5-htp? Works surprising well for my qualify of sleep where melatonin does zilch. Of course, turning down the temperature in bedroom works surprisingly well too.

@ TrUTH:

But you see, the attorney general failed to understand that the herbs were homeopathic preparations( i.e. not present).

re @ 122 altho' I am not Kreb:

- I tried 5-htp and had little reaction at al. I still have soon.
- melatonin did nothing- including none of the so-called vivid dreaming ( I know,I know, it's not the anti-malarial)**
- I used St John's Wort and did feel like eating more than I would usually but nothing else***- so forget that
( another person I know who suffers from depression felt that it might have helped a little after several days)

Oddly enough, I have found that occasionally caffeine does seem to alleviate mild depression.

** someone gave me a few pills prior to a long, late flight and it did absolutely nothing: I have very rarely slept on a plane- .. maybe 20-30 minutes twice- EVER
*** altho' less appetite can be a symptom of depression btut I don't think so in this case..

By Denice Walter (not verified) on 28 Mar 2015 #permalink

TrUTH,

Have any experience or knowledge of 5-htp? Works surprising well for my qualify of sleep where melatonin does zilch. Of course, turning down the temperature in bedroom works surprisingly well too.

I had some experience quite a few years ago. The first time I took 5-HTP I slept like a baby, and was very impressed. Subsequent times I took it it had no discernible effects at all, on my sleep or on the mild depression I was suffering from. I assume my initial experience was coincidence or the suggestion component of the placebo effect. Turns out there is no convincing evidence for 5-HTP for (or against) either sleep or depression, though it's unlikely to be harmful unless you take it with an SSRI (I doubt that would be harmful either, but why take the risk?). Melatonin does diddly-squat for me too, BTW. I used to find valerian worked for me, though again the evidence base is poor (and it stinks).

By Krebiozen (not verified) on 28 Mar 2015 #permalink

Good gravy, Krebiozen, that is fascinating. It's a nice effect, how the author focused the light of Venus onto his webpage to produce that purple font.

I'd never heard of Venus Stella Errans. I'd also thought that a homeopath had to have a substance in hand before they diluted it all down the drain, but clearly that's not the case with Venus, or with the sun- and moon-based remedies Mr. Wilkinson mentions.

He also mentions an aspect of homeopathic proving I hadn't thought about before, but it's rather unethical, especially if it ever involves quantities with physiological effects. The chap explains that he gave the "remedy" to a bunch of people without telling them what it was, then had them record any effects. That practice would be hard to reconcile with the ideal of "informed consent."

It would be so weird to live in the universe homeopaths think they do.... but it would make sense of certain things. One of the big defense contractors must have constructed a lens to focus the light of Mars onto the U.S. Capitol, and that is why we may be pivoting toward war with Iran. Good on you, palindrom (which I think/hope is your usual spelling?), for putting it to better use.

PGP, sorry for bringing up a phobia. 'Twas not the intent. If you feel like homeopathic nitrous oxide might reverse any lingering ill effects, I'll pipe some into your tap water.

Zebra:

It's been amply demonstrated on RI that there is still area under the alt-med curve as insanity approaches infinity. Homeopathy is pretty far out there; it's got no medical benefits, carries risks, costs money, directs attention away from real medicines, and is marketed with lies; that the packaging may also contain the "Quack Miranda Warning," i.e., "This product is not intended to treat...," &c., doesn't magically make those problems go away. No reasonable or informed person could see this as an acceptable state of affairs, but you've dedicated yourself to proving as clearly and frequently as possible that you're neither reasonable nor informed. It's not clear to me why you've elected to do this, but people do odd things.

@ Denice Walter

For some reason your comment just reminded me of this line in Mel Brook's "History of the World Part 1"

"Nothing, I have absolutely nothing for sale!"

Oddly enough, I have found that occasionally caffeine does seem to alleviate mild depression.

Yeah, there is quite a bit of literature on this, although a lot of it is on behavior mice and rats. Regular caffeine consumption is actually correlated with lower rates of depression in humans. (Women, at least.)

I find coffee somewhat happifying myself, although it tends to increase anxiety levels as well, so it's kind of a double-edged sword. (Depression and anxiety, of course, very often being comorbid, as they are for me.)

Krebiozen,

It is interesting that it had that effect on you only the first time.

My first time, it gave me diarrhea and stabbing pains in my abdomen yet it made my mood so buoyant that I didn't care. Since I couldn't quite square my body hurting like that even if I was euphoric, I was very hesitant to take it ever again. But self-experimenter that I am, I tried it several times after that. It was enough times that the the pain, diarrhea and euphoria went away but it still did nothing for my sleep.

However, after reading that taking it at night it ends up as melatonin downstream, I decided to try it again but this time just before bed. I also increased the dose to 100mg. Bingo! That worked really well.

BTW, valerian did nothing for me. Nor did trazodone or zaleplon for that matter. As you can probably tell I'm a big believer in individualized medicine. But, since no one is going to pay for that process, I'll stick to self-experimentation (much to the consternation of my GP although in some ways I think he finds it amusing).

And, hat tip for the advice on taking it with antidepressants; I read where that can be very dangerous.

@ Denice Walter

"Oddly enough, I have found that occasionally caffeine does seem to alleviate mild depression."

This doesn't really surprise me as there is speculation on the impact of dopamine on depression as much as there is any other neurotransmitter being discussed in biopsychiatry.

I've found 5-htp gives me vivid dreams. Many times they are comical but the disturbing ones are enough to make me wish it didn't have that effect.

JP:"necdotally, I found it helpful, but a large part of that might have just been that doing something feels better than doing nothing. I definitely wouldn’t recommend it to anybody over an SSRI or something, since the preparations vary widely in terms of concentration and so on, and the stuff has a lot of drug-drug interactions. Again, I was taking it because I didn’t have insurance. I think I took two droppersful full of it each day, which I might have been told to, or I might have made up myself. Hey, I was like 19.
The tincture actually tasted horrible – I recall mixing it with watered-down grape juice. Those Ricola cough drops taste great, though. Sometimes I eat them when I’m not even sick."

I never took it, mostly because I like having a liver, and those drug-drug reactions worry me. It's interesting that echinacea doesn't have much of an effect. Then again, very few things affect colds.
I will own up to using homeopathic shampoo, but that's more out of desperation and the fact that I'm a bit of a Scrooge.

By Politicalguineapig (not verified) on 28 Mar 2015 #permalink

I never took it, mostly because I like having a liver, and those drug-drug reactions worry me.

It's not so much that it's bad for your liver as that it blocks the effects of some drugs, one of them being a retroviral, so kind of a big deal if you were taking that. I wasn't on any drugs when I took it, though, so that wasn't a worry.

I will own up to using homeopathic shampoo, but that’s more out of desperation and the fact that I’m a bit of a Scrooge.

You could do like I do and shave your head. You will save oodles (not that much, really) on shampoo.

BTW, what makes a shampoo homeopathic?

Oh, I bet I get it: you dilute the shampoo.

I just recently found out that you're supposed to dilute Dr. Bronner's before you use it. I figure it sort of gets diluted anyway, since I only use it in the shower.

And I don't care if it's hippie soap with a bunch of weird and entertaining nonsense on the bottle, it makes the whole apartment smell like peppermint in the morning.

"Dilute dilute!"

I thought everyone who bought Dr. Bronner's had read that much, even if they skipped the weird religious rantings. (That's not me being anti-religious: my religious friends describe them similarly.)

Melatonin does diddly-squat for me too, BTW.

"[V]ery weak ... histamine (H1) antagonist properties" aside, I've found 7.5 mg of mirtazapine to be quite effective as a sleep regulator. It does not seem to suffer the "poop-out" common to OTC antihistamines, if my experience with wash-out intervals is any guide.

Despite assurances to the contrary, though, similar considerations lead me to believe that my associated weight gain cannot be accounted for as a simple by-product of H1-based appetite increase.

Given that I have a reserve, though, it's a go-to on occasion. I don't know whether it's tried before the Z-drugs for primary complaints of sleep problems, but I'd be curious to know the reason why if it's not.

^ "weight gain at therapeutic doses"

You could do like I do and shave your head. You will save oodles (not that much, really) on shampoo.

BTW, what makes a shampoo homeopathic?

Time to mention again the No Poo Movement, I suppose.

I thought everyone who bought Dr. Bronner’s had read that much, even if they skipped the weird religious rantings. (That’s not me being anti-religious: my religious friends describe them similarly.)

I'd scanned the bottle before, I think, but not read it totally in depth; the print on the 16-oz. bottles gets fairly tiny in parts. I think I read the entire thing in the bathtub recently for whatever reason. I used to read everything on everything growing up, from cereal bottles to shampoo to cleaning products, out of a general hyperlexia-type-thing, I suppose, but the amount of reading I do these days for grad school rarely leaves me even peckish.

^ My mom had some sort of medical encyclopedia - it was a big, huge, navy blue book - that I read pretty much from cover to cover at the age of 5 or so. We never had to have the "where do babies come from" talk.

Time to mention again the No Poo Movement, I suppose.

There is a similar sort of thing wherein you are supposed to not wash your face for months and it will cure any skin problems, because something something paleolithic something. I read about it a bit on the interwebs and somebody was talking about "flaking" of the skin which was pretty gross.

Homeopathy is pretty far out there; it’s got no medical benefits, carries risks, costs money, directs attention away from real medicines, and is marketed with lies; that the packaging may also contain the “Quack Miranda Warning,”

Does it? I'm insufficiently motivated to walk over to Walgreens at the moment, but I don't recall seeing this on "Oscillococcinum" – and if Z. is going to whinge about OTC, this is the mother lode – packaging.

My mom had some sort of medical encyclopedia – it was a big, huge, navy blue book

Like this?

That might be it, actually, although the cover was a little bit different, I think - possibly a different edition. It had gold lettering, I seem to remember.

Hmm. On second thought, that might not be it - I'm pretty sure it said "medical encyclopedia" on the cover, which I imagine is what led me to read it, having encountered some encyclopedia sets at cousins' houses.

Re: hyperlexia: I was using the term rather loosely, and I'm rambling a bit here, but according to Whackyweedia, somebody named Rebecca Williamson Brown posits that there are two types of hyperlexia, one of which is:
2. Hyperlexia marked by an accompanying visual spacial motor disorder.
I did have to go to special, one-on-one PE classes in kindergarten and first grade, due to extreme lack of coordination, and, it seems, understanding of spatial relationships in general. I also had a famously bad sense of direction growing up, but I partly attribute that to growing up in a place where there was one road, and you could obviously only go two directions on it.

Re: the Internet: I was in Krakow a couple years ago, living with another Rebecca, and a friend dropped in to say hi and asked Rebecca what I was doing, to which she replied, "She's in her room reading the Internet."

"....I’ve found 7.5 mg of mirtazapine to be quite effective as a sleep regulator."

Does it give you a wicked sleep hang-over the next day?

Very low dose doxepin is often referred to as the "strongest antihistamine" known. I can attest that it knocks you the heck out, but its next day effects are horrible.

Side note on The Merck Manual. The physicians at the hospital where I worked seemed to take a very dim view of it. Not sure why.

1) Re. regulating homeopathy in the US:

Make all of the product packaging carry wording along the lines of 'This product is sold for entertainment purposes only.'

2) New and uh-oh dep't:

I just ran across this on the Beeb: Naturopathy and herbalism on the loose in the Caribbean to 'treat' Chikungunya. (Sorry about posting something that's off-topic, but Orac said that's fair if it occurs further down the line, and 12 ^2 comments (that's 144:-) ought to be far enough down the line that this is OK.)

http://www.bbc.com/news/world-latin-america-32034349

'Ms Berzas is one of a growing number of sufferers who turned to natural remedies to alleviate the symptoms.'

'"When I got desperate I went to Dr Amu, the naturopath. He gave me two teas to drink and an oil to rub on my skin. It soothed the rash and diminished the pain a lot. It didn't go away but at least it was manageable," Ms Berzas recalls.'

To the extent that any of those 'remedies' are at all helpful, it's by providing symptomatic relief. In which case we should send in the scientists to ascertain if/what active compounds are present and refine them into real medicine, with standardised dosages and guaranteed purity.

No doubt there are also numerous overt quacks at work in the region, and no doubt that some of our favourite quacks such as Mike Adams will get on the proverbial band wagon once they see the Dollar signs.

Someone who has decent contacts at the Beeb ought to weigh in on their article. And whilst it did include some sceptical words at the end, they were rather weak compared to the overall tone of it.

I’m pretty sure it said “medical encyclopedia” on the cover
Pears' Medical Encyclopaedia was huge & navy-blue.

By herr doktor bimler (not verified) on 28 Mar 2015 #permalink

I’d also thought that a homeopath had to have a substance in hand before they diluted it all down the drain, but clearly that’s not the case with Venus, or with the sun- and moon-based remedies Mr. Wilkinson mentions.

There is homeopathic black hole (prepared from light focused from Cygnus X-1).
http://www.homeovista.org/provings/html/cygnus_x-1_proving.html
Also "Lux Solis britannicae", i.e. homeopathic English Sunlight, which only a cynic would describe as sufficiently diluted already.

By herr doktor bimler (not verified) on 28 Mar 2015 #permalink

Ah! I found the book!

It's only 896 pages, which is still pretty big to a 5 year old. I recall that it had a fair number of detailed illustrations, including cross-sections of the womb-with-developing-fetus. It was from the 70s and had a funny entry on homosexual behavior in adolescents, as well.

Pickwick @125 -- I spell it "palindrom" because I inadvertenty dropped the "e" off the end when I first logged onto the old, pre-facebook Huffington Post, and never changed it.

I'm still P'd O about how HP cut off their old commenters at the knees. Though of course publishing, e.g. Dana Williams is a lot worse in the long run.

Then again, they published stuff from Robert Lanza, which has great comedy value.

By palindrom (not verified) on 28 Mar 2015 #permalink

#98

Thanks for the reference. I don't need to read the critical response; there is no scientific evidence there that OTC properly constituted homeopathic formulations have direct adverse effects. (1)

Of course, to suggest otherwise puts one to the wackier side of the anti-vaxxers; at least they can point to an ingredient they claim is the problem. If you have an allergic reaction to drinking distilled water, you are in big trouble already, whatever the label says.

(1) by the definition of the study-- not indirect harm from not using conventional medicine.

#104

If you would leave out the parts directed specifically against homeopathy, you could then argue that it is not special pleading. But you don't.

If you prohibit claims that the product can treat something, it wouldn't matter if it were ginger tea or homeopathic ginger tea, right?

Likewise changing the law-- getting rid of HPU but allowing herbals and vitamins doesn't appear objective. And any change of any magnitude is highly unlikely in the current legislative environment.

But in any event, you can't prohibit the *sale* of something that is harmless; you can only prohibit *claims*, and you nor anyone else has suggested something that would be more effective than what we have now. Which isn't very.

And by the way, I know you don't like the relative harm approach, but if we are going to spend more money on testing the purity of things, we should begin with the food supply. Get that passed first and then we can start worrying about whether the number of molecules in some water is zero. E coli and listeria are much bigger threats.

#125 pickwick

" that the packaging may also contain the “Quack Miranda Warning,” i.e., “This product is not intended to treat…,” &c., doesn’t magically make those problems go away. No reasonable or informed person could see this as an acceptable state of affairs,"

So what would be "an acceptable state of affairs"?

As I said to O'Brien above; you offer no concrete alternative; just saying "the FDA should do something" isn't worth saying.

zebra,

not indirect harm from not using conventional medicine

So indirect harm doesn't count? A bit like how suffocation only causes indirect harm by not providing oxygen?

By Krebiozen (not verified) on 29 Mar 2015 #permalink

Before we continue with this conversation any further, please define what you mean by special pleading. The way I see the term used does not match what you are saying, so I need to understand what you actually meant.

By Mephispheles O'Brien (not verified) on 29 Mar 2015 #permalink

#153

Oh please, your #84 was in response to:

"1) If you are talking about OTC, there is a whole lot of stuff out there of little value– and that includes vitamin supplements, which are displayed for sale with just as much implied legitimacy as anything else, perhaps more. And then there’s the advertising, for just about everything, including cosmetic-type treatments that “rejuvenate your skin” or “give you healthy hair”.

It’s all woo, people. And you can’t do anything about it because there’s money to be made, and you have no evidence of harm– personal anecdotes and speculation about what might happen are not science. "

The study you cited had no relevance to that. Boo hoo, you got caught. Next time, make sure not to tell me where I can read the full article.

@MikeMa (going all the way back to comment #1), a FB friend just raved (settings set to public) thusly: "I had my first visit with [redacted] this week. How refreshing to sit with a doctor for almost 90 minutes who took down notes from my childhood up until today with regard to infections, diseases, antibiotics, etc. to form an entire picture of my health. Now, after results of some bloodwork, we can sit and discuss WHY certain things are the way they are with regard to possible food insensitivities, allergies, etc. rather than just treating the symptoms." The time spent I believe is crucial, and it's really all how shysters work. They work to earn your confidence and, in most cases, that requires a certain investment of time. Of course, there was so much more in the post and in the comments to follow...the expected comments re insurance not covering it with others commenting that insurance will cover the visits, but not the supplements, their rates being comparable to doctors, etc. I truly don't understand the whole MDs-treating-only-the-symptoms-not-the-cause trope. When my husband went in with appendicitis, he was given pain relief for the symptoms, but they also seemed truly interested in getting to the "WHY" and removing it. Literally. Personally, I wouldn't be able to give any detailed accounting of infections and antibiotics going back almost 50 years (aside from the biggies), but if I were of a certain persuasion, I might feel pressured into at least "remembering" something, especially if I was spending all this money and time, making this whole treatment framework very shaky, indeed.

"I truly don’t understand the whole MDs-treating-only-the-symptoms-not-the-cause trope."

I wished I lived in your world but I'll spare you the anecdotes.

To be fair, I've had MDs who've looked for the cause of my symptoms but that seems to happen much less than in the past; they just don't have the time.

Yet for all of the interviewing time naturopaths provide, I haven't found them to be any different in the only-treat-the-symptoms approach either.

zebra@155
Consider a homeopathic fire extinguisher. We world allow what's essentially a super soaker to be sold as a legitimate fire extinguisher because using it instead of the real has the potential to cause harm. In the same way we should not allow homeopathic asthma inhalers or vaccines to marketed as legitimate medicine because of the potential to cause harm. When there's even a hypothetical potential for mortality or morbidity and zero upside we would do good to be proactive instead of reactive.

RE: what to do
Require packaging to include "This product contains no active ingredients" and "this product is not meant to replace x" where is the real medicine in a large-ish font on the front. Stop them from making treatment claims. These would be a start at least.

By capnkrunch (not verified) on 29 Mar 2015 #permalink

We world allow what’s essentially a super soaker to be sold as a legitimate fire extinguisher because using it instead of the real has the potential to cause harm. -> We wouldn't allow what’s essentially a super soaker to be sold as a legitimate fire extinguisher because using it instead of the real thing has the potential to cause harm.
where is the real medicine -> where x is the real medicine
Phone typing...

By capnkrunch (not verified) on 29 Mar 2015 #permalink

#158 capnkrunch,

I decided to do a little research on my own and looked at a few (homeopathic) things for sale on Amazon. One of them used the line "regulated by the FDA as an OTC medication". Others (also labeled homeopathic) had no such claim.

Apart from that claim, which I assume is associated with the law validating the Homeopathic Pharmacopeia, which would have to be changed by US Congress, these products are no different from herbal remedies or vitamins or anything else in how they market themselves.

I have said multiple times that if you want to establish a universal standard of some kind for labeling, and if you want to fund an agency that is independent of industry influence to ensure the safety of all the products we consume, I'm all for it.

However, we already have all these disclaimers on various products, (see Amazon), and it doesn't appear to make much difference. And the complaints here still have the appearance of "regulate his woo not mine."

Apart from that claim, which I assume is associated with the law validating the Homeopathic Pharmacopeia, which would have to be changed by US Congress, these products are no different from herbal remedies or vitamins or anything else in how they market themselves.

Thus demonstrating your inability to research. A significant difference between homeopathic "medicines" and herbs/supplements is that homeopathic products can make actual treatment/cure claims, while herbs/supplements are limited to structure/function claims. Homeopathic products also are not required to carry the quack miranda warning.

Those major differences aside, many homeopathic products are marketed in a way that caters to consumers' desires for "natural" products, which makes their marketing more similar to herbs/supplements. But zebra grossly overstates the situation by claiming there is no difference. Just part of his attempt to argue that the marketing of homeopathic products is insignificant because "ZOMG! Herbs and supplements!"

What zebra continually fails to comprehend is that the rest of the commenters here are trying to keep the conversation on topic to the original post. Yes, the marketing of herbs/supplements as being able to treat/cure illnesses is a matter that needs to be fixed. However, this discussion (and the original post) is about homeopathic products. Talking about one topic does not mean the other topic is any less important; it's staying on subject. But zebra prefers to derail conversations to perseverate on his chosen obsession.

zebra--

OK, I'm going to assume you are sincere about wanting to direct effort in a useful direction. If so, you would do better to stop posting here, where you are not likely to convince anyone, and spend the time you're wasting on what you admit is your case of SIWOTI syndrome on the things that you are telling us are more important than the labeling/marketing of homeopathic crap. Or at least start your own blog where you can urge other people to work on the issues you consider important: "don't focus on X, because my vaguely related issue Q is more important" is unlikely to do anything except take your own time away from Q and, at worst, convince other people that people who care about Q are selfish, obnoxious, and generally not who we want to be working with.

zebra,

The study you cited had no relevance to that.

You wrote, I assume referring mainly to homeopathy, since that is the subject of the OP and this discussion (my emphasis):

It’s all woo, people. And you can’t do anything about it because there’s money to be made, and you have no evidence of harm– personal anecdotes and speculation about what might happen are not science.

I cited a systematic review titled, 'Adverse effects of homeopathy: a systematic review of published case reports and case series' which concluded:

Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly.

How can you possibly claim it has no relevance to your claim that there is no evidence of homeopathy causing harm? Are you suggesting that a systematic review that included 38 studies and 1,159 patients is "personal anecdotes and speculation "? Or are you claiming that case series and case histories are not science? If so, what other form of evidence could possibly demonstrate the adverse effects of homeopathy?

Boo hoo, you got caught.

What are you, a 7-year-old? Got caught doing what?

Next time, make sure not to tell me where I can read the full article.

Firstly I cited a perfectly relevant systematic review to prove yet another of your assertions wrong.

Secondly, I'm interested in an honest discussion about this, and your assumption that I was trying to deceive you, despite me giving you a link to the full text of a study you were apparently unable to find on your own, tells me a lot about your character.

Thirdly, I'm curious, given the title, what did reading the full article tell you that the abstract did not?

By Krebiozen (not verified) on 29 Mar 2015 #permalink

I finally know what ails me ---- "SIWOTI syndrome".

Perhaps this is the first step ... to a cure. Perhaps -- perhaps, I can change.

Of course, like the lightbulb changed by the single psychotherapist -- I'd have to want to change.

By palindrom (not verified) on 29 Mar 2015 #permalink

Step 1: We admitted we were powerless over People Being Wrong on the Internet -- that our lives had become unmanageable.

By herr doktor bimler (not verified) on 29 Mar 2015 #permalink

#161 So ToddW, is this your idea of not engaging or are you going to reserve that for when I demonstrate that your are incorrect?

1)

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2)

Arthritis pain formula.
Natural Relief for Minor Muscle and Joint Pain
100% Natural, Acid Free, Soft tablets dissolve instantly
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Aspirin and Acetaminophen Free
Can be used in conjunction with other medications.

Yeah, what a big difference in the advertising. What exactly is the giveaway? "Joint relief" v "pain relief"? That's the Horrible Danger of homeopathy? Maybe you people are so obsessed with this trivial distinction that you can tell the difference, but how would it affect the typical consumer?

Ridiculous.

Zebra -

So there was no Quack Miranda Warning on the label of that supplement? That's surprising; I wonder if that's legal?

Your view is that the difference in labeling laws for supplements and homeopathic products is trivial and there are no differences discernable by a typical consumer. Therefore, your belief is that makers of homeopathic products wouldn't care if their products were subject to the same labeling laws as are supplements.

By OccamsLaser (not verified) on 29 Mar 2015 #permalink

zebra@167

#161 So ToddW, is this your idea of not engaging or are you going to reserve that for when I demonstrate that your are incorrect?

I can't help but note that you've ignored my comments about homeopathic asthma inhalers twice. Projection much.

By capnkrunch (not verified) on 29 Mar 2015 #permalink

OccamsLaser,

So there was no Quack Miranda Warning on the label of that supplement? That’s surprising; I wonder if that’s legal?

For some reason zebra has omitted to mention the quack Miranda warning on the Amazon page selling the supplement:

Legal Disclaimer
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

There is a lot of material between the claims made for the product and the warning, which seems to me to be in violation of DSHEA rule 11:

Where must I place the disclosure statement?
You must place the disclosure statement immediately adjacent to (i.e., right next to) the claim with no intervening material (such as vignettes or other art work) other than information in the statement of identity or any other information that is required to be presented with the claim.

The homeopathic remedy has no quack Miranda warning, just a general warning from Amazon, not the remedy seller:

Information and statements regarding dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease or health condition. Amazon.com assumes no liability for inaccuracies or misstatements about products.

Since a homeopathic remedy is by no stretch of the imagination, nor legally, a dietary supplement, I think it is fair to say there is no warning on this advertisement, which is perfectly legal for homeopathic remedies under DSHEA rules.

Interestingly, the FDA states that:

In the Federal Register of April 1, 1983 (48 FR 14003), the Agency proposed to amend 21 CFR 211.165 to exempt homeopathic drug products from the requirement for laboratory determination of identity and strength of each active ingredient prior to release for distribution.
Pending a final rule on this exemption, this testing requirement will not be enforced for homeopathic drug products.

So not only can homeopathic remedies be advertised with medical claims, they can also be sold without being checked for purity and strength first. I suppose this is how those children suffered belladonna poisoning a few years ago, when a homeopathic teething remedy turned out not to be homeopathic at all.

By Krebiozen (not verified) on 29 Mar 2015 #permalink

Krebiozen@170

For some reason zebra has omitted to mention the quack Miranda warning on the Amazon page selling the supplement:

I'm sure it's not the case but it's almost as though he's being intentionally dishonest.

I'd also note zebra continues to fail to miss the point it's not a this or that deal. Orac and his minions are not fans of supplement/herbal remedies either well but the issue at hand is homeopathy because of the FDA hearing. I'm sure it's not the case but it's almost as though he's being intentionally obtuse.

On top, I'm planning on writing to the FDA RE: this hearing but have no idea to start and I've never written anything to any part of the government. I wonder if someone might share what they are writing or part of it as an example.

By capnkrunch (not verified) on 29 Mar 2015 #permalink

JP: Yep. In fairness, the prices they charge for travel hair care is ridiculous, and there's only so many bottles one can appropriate from hotel rooms. Also, we have another square on the 'are you sure you aren't my clone card?' I also read everything on my cereal boxes, and I may have to purchase the soap for the entertainment value.

Narad: Oh god. No, I haven't heard of it, and gross.

By Politicalguineapig (not verified) on 29 Mar 2015 #permalink

I may have to purchase the soap for the entertainment value.

I recommend it. The peppermint is by far my favorite, although the almond-scented one is nice also. If you just want to read the packaging, you can probably find some examples on the interwebs.

@capnkrunch

I’m sure it’s not the case but it’s almost as though he’s being intentionally obtuse.

Precisely. He does, however, serve as a good teaching example of mistakes in logic and reading comprehension. I mean, he tried a "gotcha" on me but used examples that proved my points. The supplement made structure/function claims, rather than any claim that it treated an actual disease, while the homeopathic product claimed to treat a disease. Further, the supplement had the quack miranda warning, which the homeopathic product did not.

Now, the supplement description does demonstrate the problems in DSHEA regarding labeling claims for supplements. They sound like they're intended to treat arthritis, but they're written in such a way that the manufacturer can state they never claimed it treated arthritis. That's one, of many, problems with supplement regulation that need to be changed.

But, again, that's not the subject of this post. Homeopathic products and how they are regulated is the subject. Talking about them can help people understand better what, exactly, homeopathic products are and why the regulations surrounding them are awful and need to be changed.

Krebiozen highlights some of the additional problems with the regulations. To sum up some of the points that have been brought up in the comments here, with some additions:

* Homeopathic remedies can make treatment claims, but do not have to prove them.
* Homeopathic remedies are not required to prove they contain what they claim they contain.
* Homeopathic remedies are not required to prove the strength claimed.
* Homeopathic products are exempt from expiration dating. (21 CFR 211.137)
* Homeopathic products are exempt from limitations on how much alcohol the product can contain. (21 CFR 328.10)

@PGP and JP
Dr. Bronner's, brought to you by the same people behind timecube. I'd buy a bottle as a conversation piece but $17 on Amazon is a little too pricey.

By capnkrunch (not verified) on 29 Mar 2015 #permalink

with some additions

It's worse than not just having to prove the claims: "[T]he FDA allows a private organization to designate which homeopathic drugs meet certain (and unknown) standards for strength, quality, and purity set forth in the HPUS. CPG § 400.400." DeLarosa v. Boiron, 813 F. Supp. 2d 1177, 1186–87 (C.D. Cal. 2011) (emphasis added).

"In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs, even if they meet the unknown standards for inclusion in the HPUS." Id. at 1189 (emphasis added).

Nothing prevents enforcement of the FDCA. As I noted above, nosodes should be a Slam. Freaking. Dunk.

Banning nosodes would require zero effort. The product is by definition violative of the law. And I kinda think that such an action would make for some easy headlines.

^ A bit more emphasis was added than I intended.

I’m sure it’s not the case but it’s almost as though he’s being intentionally obtuse.

Oh, I don't think intentionality enters into the obtuseness in the slightest.

I decided to do a little research on my own and looked at a few (homeopathic) things for sale on Amazon. One of them used the line “regulated by the FDA as an OTC medication”. Others (also labeled homeopathic) had no such claim.

Apart from that claim, which I assume is associated with the law validating the Homeopathic Pharmacopeia....

Why, pray tell, would you assume this?

And while you're making associations, could you also "do a little research on your own" and identify the "validating"* law in assumption?

* Some particulars of this, ah, "term of art" would also help.

Oh, right. Because this:

... which would have to be changed by US Congress

I think it is fair to say there is no warning on this advertisement, which is perfectly legal for homeopathic remedies under DSHEA rules.

Wait, what? DSHEA (PDF) is orthogonal to homeopathics. [It's sufficient to see Section 3(a).]

Capn' krunch- No, he's not quite as bad as that poor man who runs Timecube.

By Politicalguineapig (not verified) on 29 Mar 2015 #permalink

@PGP and JP
Dr. Bronner’s, brought to you by the same people behind timecube. I’d buy a bottle as a conversation piece but $17 on Amazon is a little too pricey.

Regardless of whether Doc Bronner was as bad as that poor man who runs Timecube, $17 for 32 oz. of Dr. Bronner's is not bad at all. A bottle that big will last you a long-a** time, and the soap is actually great, at least in my opinion. Although one should note that the peppermint variety, my favorite, will make your sensitive areas tingle. Which may be good or bad, depends on the person, I guess.

Narad,

Wait, what? DSHEA (PDF) is orthogonal to homeopathics. [It’s sufficient to see Section 3(a).]

That's what I meant, though I expressed it rather clumsily, that since homeopathic remedies are not legally dietary supplements, they do not fall under the DSHEA and do not have to provide the same disclaimers.

By Krebiozen (not verified) on 30 Mar 2015 #permalink

#168

My belief, which I've stated clearly, is that each interest group would like to increase their profits. So attempting piecemeal regulation changes is easily construed as being driven by industry influence, and offers a useful argument for the group being singled out.

The examples I gave, including the fact that I didn't find everything on the Amazon page, illustrates the point I've also made previously-- it's all advertising gibberish, and disclaimers may or may not be hidden or obscure, but there's nothing there that would drive a choice between the two.

Purchasing decisions will be made based on the comments, and maybe the color of the bottle or the typography or any number of well-established marketing techniques.

If someone is looking for an alternative medicine in the first place, why would even a bold-print disclaimer influence them at all? It would just be seen as the work of Big Pharma.

#169 You offer nothing different from what I supplied-- it's advertising gibberish that claims to relieve symptoms. If people give testimonials on Amazon that it works, people will buy it. Just like anything else.

Oh, I don’t think intentionality enters into the obtuseness in the slightest.

Indeed, I recall his having trouble a while back understanding pretty basic English words like "and" and "but."

An observation about the problems with homeopathic products, herbal supplements and OTC drugs:

A the grocery store yesterday I noticed three boxes of products for yeast infections. All three boxes had the same brand name. One was an herbal supplement, one was a homeopathic remedy and one was a normal OTC drug.

I have no idea if any of them work, and they were only about a dollar cheaper than the normal yeast infection treatment (right next to them on the shelf). How on earth could your average consumer, who is presumably uncomfortable and in a hurry, make a smart choice?

Clearly the company making these things knows how to expand their market share.

By JustaTech (not verified) on 30 Mar 2015 #permalink

@zebra

I understand your wishes to have the scientific thinkers here spend more time on the complicated abuses in medicine that confound lay people and that we could never discern without their help rather than on something like homeopathy.

What I don't understand is why you expect it from them. It is kind of like expecting charity, isn't it?

I also don't understand why you have placed yourself in the position of defending the indefensible. Homeopathy - a whole lot of nothing.

Regardless, I don't think that you need to worry. If medicine continues down its path of behaving like a business, it will be bad enough that the abuses in it won't be able to be ignored.

I expect that those abuses will involve a fair amount of alternative medicine because that is what they'll be selling us since it comes cheaper than an MD and high priced medicine and equipment..

So I guess you'll be on the same side then.

zebra@186

You offer nothing different from what I supplied– it’s advertising gibberish that claims to relieve symptoms. If people give testimonials on Amazon that it works, people will buy it. Just like anything else.

Seriously? You don't see anything different between arthritis pain and shortness of breath? I'm don't have high hopes but I suppose I'll hold your hand and walk you through the my logic anyways.

Arthitis pain while debilitating is not a life threat. Treated or untreated it won't kill you. Shortness of breath is a legitimate medical emergency, especially in a patient with a history of asthma. Using sugar pills instead of NSAIDs for arthritis might decrease quality of life but almost certainly won't be fatal. Using flavored water spray instead of albuterol is potentially life threatening.

Is that good or was it the asthma as a life threat part you don't get? Should I explain the pathophysiology of asthma and mechanism of action of albuterol as well? Maybe I should start at the beginning with cellular metabolism and how the brain needs a constant supply of oxygen and glucose to survive. Do you want some sources that show asthma can kill and arthritis doesn't?

As for my other point, I'm getting tired of repeating it so I'll just quote myself from #172:

I’d also note zebra continues to fail to miss the point: it’s not a this or that deal. Orac and his minions are not fans of supplements/herbal remedies either but the issue at hand is homeopathy because of the FDA hearing.

Unfortunately, I don't know how to walk you through this any simpler but I'm more than willing to hold your hand for moral support anyways.

By capnkrunch (not verified) on 30 Mar 2015 #permalink

Is it not maybe a good thing that people believe in homeopathic medicine? Surely it means that they won't be pumping their bodies full of the toxic chemicals found in traditional medicine?

By Mikaela Nicolau (not verified) on 30 Mar 2015 #permalink

@Mikaela

You mean you'd rather them take sugar pills and die from their maladies, rather than take those nasty chemicals what will save their lives?

Is that the argument you're going for? Better for them to suffer or die with homeopathy, than take evidence based medicine and live for a longer period?

@190

Oh the humanity!

You still haven't offered a response or solution. You still haven't given any evidence-- scientific evidence-- that changing a few phrases on intentionally vague and confusing advertising is going to make a difference to any purchasing decisions, or treatment decisions. Why don't you have the integrity to say: yeah, I get your point? What's next, "think of the children"?

And please, enough with the strawman. My either-or is, very clearly stated multiple times, between a comprehensive approach and a piecemeal approach. You know, forest and trees, and all that? Error of composition/distribution?

Well, maybe you don't know...

Wait, what...

People are saying here that all they want from the FDA is to replace one vaguely worded advertising slogan with a different one?

And here I thought that was what people would think the likely outcome of the hearing would be (if there is any outcome at all) rather than what SBM types would want the outcome to be.

And yeah I get that every single industry has its lobby and its people who go to Washington and buy influence to protect its industry from regulation. That is why I don't believe this hearing will do anything that seriously tackles the problem. Everyone knows who they have to buy and very few people refuse to be bought.

I'm shocked they even managed to even get a hearing put on, so maybe some hope in all the despair of humans only buy things based on pretty colors and everything in the world is bought and paid for by corporations out to doom us all.

@Darwy 192: I had a strange feeling about #191 - not sure why, perhaps its ignorant brevity - but a quick run through the googles revealed another "Pretorius" connection. Narad caught one of these yesterday... and recalled that it was also
seen last spring.

Either the University of Pretorius offers a course in succinct, scientifically illiterate writing, or there is some kind of bot spam issue with these.

By CTGeneGuy (not verified) on 31 Mar 2015 #permalink

Nice find, Notchka. And to think that I thought these comments were the product of mindless, computer generated trolling – nope, student homeopaths.

Halfway down the second page of the document you found, regarding student assessments… “They will also be confronted by an ethical dilemma.” Oh they sure will.

By CTGeneGuy (not verified) on 31 Mar 2015 #permalink

#194

SBM types here, at least, don't do a very good job of articulating what they would like, that's the problem.

Public policy involves more than sitting around tittering about 'how silly those people are'; you need to propose a fix that is perceived as fair and reasonable, enforceable, and so on.

Care to give it a try?

zebra@193
I believe that I saw elsewhere a commenter say you are as slipperly as an eel. That certainly rings true. Your last comment was regarding "special interest pleading" and the lack of difference between the examples you and I provided. Now your complaints have changed to my lack of solutions, lack of scientific evidence behind solutions, and you're still harping on this not being comprehensive enough.

Homeopathy already occupies a special position relative to herbals/supplements. Barring disease claims and requiring the quack Miranda warning actually makes things even. At that point wholesale regulation actually becomes easier because you can group everything together. As it stands now, comprehensive regulation would require special specific clauses regarding homeopathy. Change is a process, we can take more than one step to get where we want to be.

I think the best and most realistic solution is if we can remove homeopathy's special status and bring it under DSHEA then work towards wholesale reform of DSHEA. The end goal being FDA oversight of herbals, supplements, and homeopathy similar to the much more strict oversight of drugs. This would include requirements to prove safety and efficacy as well as manufacturing requirements for purity and content before even vague, meaningless, but nonetheless medical sounding structure/function claims can be made. A happy (and I believe optomistically realistic) middle step is that homeopathy can no longer make unsubstantiated treatment/cure claims and include the quack Miranda but that is by no means the end goal.

An alternative would be to allow homeopathy to retain its ostensible drug status but require proof efficacy, safety, purity, and content the same as real drugs. No matter how you slice it, in relation to drugs or in relation to supplements/herbals homeopathy has a privledged position. In order to have effective regulation that needs to be taken away. And, once again, the hearing at hand involves homeopathy which is why discussing how to regulate homeopathy is relevant. Discussing how to fix DSHEA stuff is a fine topic but in this particular forum is in fact irrelevant because it is not the topic of the FDA hearing. I'd also note this is the case not because of team Orac but rather the FDA's decision*.

*to be fair though we all sacrifice our goats to the same Dark Overlord, King of Lizards and and Ruler of Men

By capnkrunch (not verified) on 31 Mar 2015 #permalink

#201

See, you can make a reasoned suggestion when you try. And I can disagree, without being disagreeable.

I think you have your politics wrong. You need to reform the system in its entirety, which means including what you call SBM. Do that, and you take away all the posturing about individual choice and Big Pharma and so on. Don't do it, and they have a very convincing case that whoever comes out ahead does so by offering the biggest bribes.

You can't keep ignoring *why* people choose to use these products. Do you think they don't watch TV and see the endless ads using deceptive and manipulative techniques to push conventional drugs with "rare but serious side effects"? Do you think they don't mock those ads the same way you mock alternativists? Me, I mock both sides, as you can see.

So that's the disagreement, and the difference in approach has nothing to do with "today we are talking about homeopathy". If you think you realistically have the power to change the law to take away the privilege for homeopathy, you are wasting that power by so limiting your effort. And you are reinforcing the perception that it is about competing industries.

People have the right to choose unproven or disproven treatments.
But, they also have the right to be informed about what they're getting and the scientific evidence regarding it.
People don't realize that many homeopathic remedy almost certainly don't even have a single molecule of the "active ingredient" in it. "30C" or "200C" is deliberately mystifying.
I wonder if Boiron even buys a duck liver or whatever it is, when starting their manufacturing process. Maybe somebody should investigate what Boiron buys, and charge them with fraud if they don't buy all those exotic ingredients that are supposedly in homeopathic remedies.

Some kind of truth in labeling is crucial.
Such as "Has a 1/1000000000000000.....0000 chance of having a molecule of duck liver"
Actually, come to think of it, there might actually *be* a molecule from a duck in homeopathic remedies - simply because at some point it will be diluted with water containing some molecules from a duck. Most water probably has SOME duck molecules, just because there are a LOT of molecules in a macroscopic amount of water.
So perhaps homeopathic remedies should have a warning label "Chemically indistinguishable from water".

Zebra, why do you say in post 202 ....including what you call SBM?
Science Based Medicine is just that, science based. Is there another definition for it?

By drugstoregal (not verified) on 31 Mar 2015 #permalink

How about finally taking flu vaccine off the 'approved' list, I mean it really does have a total history of woo behind it's conception and application. This year, fancy telling us it is only 3% effective, if that was a homeopathic remedy...........

Maybe flu vaccine is homeopathy, a little of what causes diseases, shaken, not stirred......................little bit of Disney and hey ho a box of tissues and Narad will go for it..........

#204

No idea what you are asking. "Science based" is a very vague term, actually, if that is what you are talking about. People also use "conventional" medicine, which is also vague. I think everyone knows what we are talking about though.

If we traveled to an uninhabited, alternate dimension Earth, and sought out some willow bark to treat a headache, would that be correctly labeled "science based medicine"? Or would we have to build a lab and synthesize it? Who cares?

Oh sorry Notchka - the Pretoria/Pretorius mixup was due to my typo. I should have said *Pretoria* in #195.

Maybe I could coax a new post out of Mikaela; let her prove her humanity...
*Ahem*. Excuse me Ms Nicolau... What toxins are you most concerned about? How are your studies going? Have you talked about Avogadro in class yet? Eagerly awaiting to hear from you.

By CTGeneGuy (not verified) on 31 Mar 2015 #permalink

If we traveled to an uninhabited, alternate dimension Earth, and sought out some willow bark to treat a headache, would that be correctly labeled “science based medicine”?

If you're doing so because it's known to contain the molecule salicylic acid, which inhibist the activity of enzymes COX1 and COX2 and possesses analgesic and anti-inflammatory properties, yes. Of course you'd have no idea what dose you were receiving or what impurities the tea might contain, which is why you'd achieve better outcomes if you did build that lab and manufacture preparationswhere the amount of active drug could be defined.
And "conventional medicine" is simply medicine that's been shown to work. Non-conventional or alternative medicine is simply medicine that either hasn't been shown to work or has actually been shown not to work (e.g., homeopathy)

#210

Well, I guess you care. OK, how about if we had no idea what a molecule is but had centuries of experimentation with methods of preparing the tea and dosages? Would that be science-based or not?

You do realize that much of our modern science was developed under such conditions, right? It was called "scientific method" in case you missed that in school.

And by your definition of "unconventional", every drug trial fits. Duh.

Why don't you stop worrying about the propaganda value of your language and learn something. Start with the history and philosophy of science, for example. Then you might see that "works" itself is not so clearly defined.

How did you happen to pick the willow? Now sometimes the various superstitions used to select a plant to try does happen upon something with an active ingredient.

What controls did you use for the experimentation? Similar looking/tasting teas from other things? Most of the centuries of experimentation claimed didn't always use either controls or systematic observational methods that had not been developed.

Again sometimes random chance favors the bold and you hit on something that works does end up being commonly chewed up or brewed.

And no matter how many experimental set ups you design to brew the tea you are still dealing with something that is going to have a lot of natural variation as the source material may have random amounts for numerous factors you are unable to control. Like how many bugs chewed on the tree last week.

#212

Again, you fail to make clear what your point is. And you show a remarkable ignorance about the history and philosophy of science.

Everything we know, and all our technology, evolved through experimentation and quantification that for you must seem terribly 'primitive', and then a more formalized version of the method itself evolved in maybe 17th century Europe. (I suspect that the case for the latter is a somewhat Eurocentric interpretation; it is unlikely that individuals engaged in metallurgy, for example, didn't do pretty much the same thing millennia prior, but of course tended to keep things secret.)

Somehow, those people managed to create civilizations, and produce the giants upon whose shoulders Newton stood, even though they hadn't been schooled by KayMarie on how to do experiments.

Well, there I go again lecturing Orac's super-scientific minions just because they seem to be as ignorant as the people they like to mock. Tsk tsk. My karma suffers yet again.

Well, there I go again lecturing Orac’s super-scientific minions....

Something that has never failed to produce tediously embarrassing performances.

This post brought up a good and interesting question: how can homeopathy be regulated so it doesn't either defraud people or violate their freedom of choice?
What does willow bark, experimentation etc. have to do with that good and interesting question?

zebra@202

So that’s the disagreement, and the difference in approach has nothing to do with “today we are talking about homeopathy”. If you think you realistically have the power to change the law to take away the privilege for homeopathy, you are wasting that power by so limiting your effort. And you are reinforcing the perception that it is about competing industries.

Come on man. It's a hell of a leap to go from my written comment that the FDA explicitly asked may have a small effect on heir homeopathy policy to you're wasting your effort because you should be changing the entire system. There's an avenue open through which I may be able to make a difference on one specific issue but you think I should ignore it because it's too narrow? Jokes about Lord Draconis nonwithstanding (praise be to his Lizardage) no one here has the kind of power to make the sweeping changes you want.

Sorry guy, you have your politics wrong. I'm but a simple paramedic. You think writing a solicited comment is a waste of effort. What should I be doing? Writing to Obama and my senators and representatives with vague requests to change the system? That strikes me as far more of a wasted effort.

@208
SBM actually has a pretty specific meaning. It is the process through which multiple concurrent lines of evidence are established to support treatment modalities. For example prior plausibilty, animal/cell models, pilot studies, and finally RCTs. This is an expansion on the currently prevailing paradigm (EBM) where RCTs are the be all end all. So I guess you example is SBM only as much as a person walking to Walgreens is practicing SBM. SBM was the process that demonstrated efficacy, buying aspirin or seeking out willow bark is the result.

By capnkrunch (not verified) on 31 Mar 2015 #permalink

Thanks for not actually answering any of my questions. So I still have no idea how without any a priori knowledge you will happen upon willow bark or if there will be any systematic observational work or actual experimentation.

Yes, pre-scientific trial and error (because last I checked the ancient Greeks predate the Renaissance by several centuries) even based on erroneous ideas sometimes found bioactive compounds.

Just becasue you find the right plant doesn't mean you did it with science, or you use a reality-based system to explain it.

If you think you realistically have the power to change the law to take away the privilege for homeopathy,

Which, as already noted, you never bothered to identify and is wholly unneccessary in any event.

you are wasting that power by so limiting your effort

So, if one were able to modify the law regarding homeopathics, one would be wasting "that power" by modifying the law regarding homeopathics? I guess that takes care of that.

I don’t need to read the critical response; there is no scientific evidence there that OTC properly constituted homeopathic formulations have direct adverse effects.

Nor, apparently, does Z. need to read the actual FDA rationale for the the hearing.

"Negative health effects from drug products labeled as homeopathic have been reported through the FDA’s Adverse Event Reporting System and the National Poison Data System (NPDS), which is maintained by the American Association of Poison Control Centers and tracks human poison exposure cases. Data in the NPDS pertaining to homeopathic drug products is tracked under the category 'Homeopathic Agents.' The 2012 American Association of Poison Control Center Annual Report indicated that there
were 10,311 reported poison exposure cases related to 'Homeopathic Agents,' with 8,788 of those reported cases attributed to children 5 years of age and younger (Ref. 3). Of the 10,311 reported cases, 697 required treatment in a health care facility (Id.)."

The specific reference is Table 22B here (PDF).

Zebra -

I understand that you prefer to maintain homeopathic medications' special exemption from laws requiring medications to show safety, efficacy, and purity rather than favoring the elimination of the separate set of regulations for homeopathics. Others here, myself included, instead favor the simplification of laws applying to medications by eliminating any separate rules for homeopathics.

Given the choice, you would keep the separate rules for homeopathics rather than eliminate them. Among posters here who know homeopathy is utter quackery, you alone hold this inexplicable position. But it is quite clear that you prefer to keep homeopathy's special status in the law intact rather than eliminate it, though you agree it is a fraudulent form of medicine.

By OccamsLaser (not verified) on 31 Mar 2015 #permalink

OccamsLaser@220
No, no, no. zebra just thinks we're better off doing nothing unless we can fix every single problem in healthcare simultaneously and with a single step. He's a realist, that one.

By capnkrunch (not verified) on 31 Mar 2015 #permalink

#219

Narad provides 'evidence' that only an anti-vaxxer would consider 'scientific'.

"Case records in this database are from
self-reported calls: they refl
ect only information provided
when the public or healthcare professionals report an actual
or potential exposure to a substance (e.g., an ingestion, inha-
lation, or topical exposure, etc.), or request information/edu-
cational materials. Exposures do not necessarily represent
a poisoning or overdose. The AAPCC is not able to com-
pletely verify the accuracy of every report made to member
centers. "

And even with the most generous reading of *this* data (which is not what my quoted comment referred to, duh) there is still nothing that shows properly formulated OTC homeopathic formulations causing harm.

#220 I've received some bit of education since I came across this topic recently, and I would say that you are correct-- you guys have convinced me. I would much prefer the FDA devote limited resources to things that have a substantial potential for harm, rather than something which is designed to have no effect at all, and is used by a tiny fraction of the population

It seems to me the anti-vaxxers are indeed the more scientific when compared to your homeopathophobic hysteria.

zebra,

is used by a tiny fraction of the population

That depends on your definition of "a tiny fraction" I suppose. From the NIH:

According to the 2007 National Health Interview Survey, which included a comprehensive survey of the use of complementary health practices by Americans, an estimated 3.9 million adults and 910,000 children used homeopathy in the previous year. These estimates include use of over-the-counter products labeled as “homeopathic,” as well as visits with a homeopathic practitioner. Out-of-pocket costs for adults were $2.9 billion for homeopathic medicines and $170 million for visits to homeopathic practitioners.

I agree that if you redefine harm to only include direct harm and properly constituted homeopathic formulations, homeopathy does little if any harm. The problem is there is no way of telling if a homeopathic remedy is properly constituted, any legal requirements for the manufacturer to check the purity of their products (if any) are not enforced, and indirect harm is still harm. For example Gloria Sam's death was only an indirect result of the use of homeopathy, but she is still just as dead. The children poisoned by an improperly constituted homeopathic teething remedy were still poisoned.

If you apply the same standards apply to conventional medicine, since properly prescribed antibiotics are not given to patients with viral infections, and yearly annual physicals do no direct harm we can stop worrying about these too, can't we?

By Krebiozen (not verified) on 01 Apr 2015 #permalink

So, if I understand zebra's position, it is that

(a) if you don't advocate for a complete fix for every conceivable fraudulent, dangerous, or ineffective health-related treatment, but you support the effort of the FDA to do something about one fraudulent, dangerous, or ineffective health-related treatment, then you are merely trying to protect your own fraudulent, dangerous, or ineffective health-related treatment;

(b) properly formulated homeopathic nostrums (which may range in dilution from 1X [10-fold] to 200C [400-fold]) are one and all perfectly safe and produced in perfectly safe, sanitary, and consistent environments and so it is a waste of time for the FDA to ever even consider regulating such nostrums the same as other OTC concoctions;

(c) relying on the only available data -- reports -- since there is no mechanism for post-release surveillance of homeopathic nostrums is obviously unscientific.

I regularly get flyers for "alternatives to the flu shot", including homeopathic "alternatives", from a pharmacy with my mail order medications.
Since the flu kills thousands of people a year, and flu shots could prevent a lot of those deaths, these fake "alternatives" could cause a lot of harm.

I don't live in the US and only visit once in a while. During one early trip I had a bad cold, and not knowing any better I walked into a CVS in Boston and bought some cherry drops which claimed to reduce a cold and had some large wording to that effect on the front. It was only later when looking at the packet more closely that I saw the word "homeopathic".

I became extremely angry. Angry with myself for being conned into buying something that didn't work, angry at the manufacturer for putting deliberately misleading statements and claims on the packaging (and tiny disclaimers), angry with the phamacy for selling this crap to me (and not even bothering to segregate the woo from real medicines) and angry with the US that it would tolerate this.

I believe at the very least that any "medicine" which is not proven to be efficacious (which can include those with "these claims have not been evaluated by the FDA" statements in micro print) should be separate and in its own area which should be at least 20 feet away in a straight line from the pharmacy counter and at least 10 feet away from other medicines. But ideally it should be banned, or the likes of CVS / Walgreens stop stocking it. It's a public health issue as much as anything else.

And even with the most generous reading of *this* data (which is not what my quoted comment referred to, duh) there is still nothing that shows properly formulated OTC homeopathic formulations causing harm.

And... you walked into that one right on cue. Do you have any evidence "– scientific evidence– " that those 697 provider-related entries (1) didn't happen or (2) must have been due to "improperly formulated" homeopathic medications?

You do realize that not all of it is trans-Avogadro, right?

Beth at #225: extremely important point.
Bad: accidentally buying a useless over the counter homeopathic remedy for a cold.
Worse: choosing homeopathic prophylaxis instead of real vaccines and getting school exemptions for one’s kids believing they are protected during disease outbreaks by their homeoprophylaxis.

And popping up in my news feed today, as if on cue… this meeting
announcement on homeoprophylaxis, boasting a Wakefield update on the "CDC whistleblower" and how-to talks on vaccine exemptions.

By CTGeneGuy (not verified) on 01 Apr 2015 #permalink

@Narad
Most likely, almost all the harm done by homeopathy is from misdirecting people so they don't find real answers to their problems.
And, the waste of money. In 2007 $3.1 billion was spent on homeopathic medicine in the USA. That was the cost of consulting homeopaths, plus the cost of homeopathic preparations. Probably it's a lot more now.
That's a lot of fraud.
The direct damage from homeopathic products isn't so important.

@CTGeneGuy
The flu vaccine also protects against heart disease.
This might lead to a vaccine against heart disease.
So when pharmacies sell fake "alternatives to the flu vaccine" - not only are they endangering people by increasing the rate of flu infections - they're also endangering people by increasing heart disease deaths.

Great news!! The Gov't of Ontario is implementing a College of Homeopaths as the governing body for the profession in the province.

Not everyone seems wildly impressed. http://globalnews.ca/news/1915649/ontario-regulates-homeopathy-greeted-…

Wildly uninformed sources (me) suggest that homoeopaths will have to demonstrate that they can distil water and alcohol (this last a possible source of alternative income) and must have memorized Avogadro's Number.

It is not clear if homeopaths with reduced arm motion will be able to have unregistered assistants do the shaking.

By jrkrideau (not verified) on 01 Apr 2015 #permalink

The direct damage from homeopathic products isn’t so important.

It is to the specific point that I'm making. You may relcall that Z. elected to condescend about others' ignorance of "the history and philosophy of science."*

The obvious question is whether he bothered to ask himself what negating an existential quantification produces.

* He is, of course, also "the master of cryptic comments," an expert in what "public policy involves," and of such towering erudition in physics and statistics that he has managed to prove that radionuclides don't have half-lives through the powerful aphorism "random is random."

^ "recall"

Given that the main hazard of homeopathy is that it may misdirect people away from real treatments, the regulation should focus on making it clear that the homeopathic preparation isn't a substitute for a real treatment - prohibit any claim on the label to treat anything; prohibit claims by homeopaths that they can treat a medical problem.
For example, advertising fake flu prevention should be illegal (and maybe it is).
If people want to use homeopathy as an adjunct to a real treatment, that isn't so alarming. It might even be useful, by making the treatment more acceptable. .
And advertising homeopathic products as adjuncts would be OK.

Beth@235

If people want to use homeopathy as an adjunct to a real treatment, that isn’t so alarming. It might even be useful, by making the treatment more acceptable. .
And advertising homeopathic products as adjuncts would be OK.

While I'd imagine this is the most likely scenario (besides maybe the nothing changes scenario) it's certainly not ideal. We all know the issues with DSHEA. Structure/function claims can be tortured into sounding like treatment claims and people still choose herbals/supplements over real medicine. And as Narad noted manufacturing standards are basically nonexistent.

I do think homeoprophylaxis and homeopathic asthma inhalers are the most dangerous and have my fingers crossed that the FDA puts the kibosh on them but even if it's just livesavers masquarading as cough drops fraud is fraud.

By capnkrunch (not verified) on 01 Apr 2015 #permalink

Structure/function claims can be tortured into sounding like treatment claims

A claim like "supports the immune system" is also a lie.
People shouldn't be lied to on the label.
By using homeopathy as an adjunct to real treatment, I meant something like, making the treatment more pleasing.
I've read that even if people are told something is a placebo, it still works as a placebo. But advertising would still have to make it clear that the homeopathic preparation is just an incantation for sale, a mind game.

#227

And Narad now joins the vaxxers and Creationists with the "absence of evidence" argument. "You can't prove the vaccine didn't cause *my* child's autism", and so on. Sorry, you claim harm, you need to prove your claim.

Putting aside your childish response, when I said "generous reading of the data" I meant accepting the subset of incidents where there was a description of some condition rather than a report of 'exposure'. Nothing there that you could use to make a case.

Also, you do understand that little kids gratuitously ingesting stuff is not an indictment of the stuff but of the parents who left it accessible, right? If some of these things contain alcohol for example, that could result in 'harm' even if there are no other active molecules.

According to your compatriots here, what we need is a nice randomized double-blind study. I'm willing to bet on the outcome of that one. You just have to be very careful to keep track of which is the placebo.

"Also, you do understand that little kids gratuitously ingesting stuff is not an indictment of the stuff but of the parents who left it accessible, right?"

With regard to the children poisoned by homeopathic belladonna, it was in the form of teething tablets, sold to parents explicitly to be fed to small children. It was used as directed, but children were poisoned anyway because (a) a homeopathic nostrum may be as little as 1X (10-fold dilution) and thus extremely potent and (b) quality control is not enforced on homeopathic nostrums and it was poor in this case. 

See 

http://www.m.webmd.com/a-to-z-guides/news/20101025/hylands-teething-tab…

zebra@238

And Narad now joins the vaxxers and Creationists with the “absence of evidence” argument. “You can’t prove the vaccine didn’t cause *my* child’s autism”, and so on. Sorry, you claim harm, you need to prove your claim.

As Narad stated, this is the best data available. When antivaxxers troll VAERS they ars ignoring mountains of high quality data. In this case there's really no need for better data. Vaccines are very high benefit so risk needs to be well documented or more people could be harmed by knee-jerk reactions (*cough*Wakefield*cough*). Homeopathy has zero benefit so actimg on low quality data showing potential harm is justifiable. In fact, generating higher quality data would be a waste of resources and time during which there more people are put at risk.

According to your compatriots here, what we need is a nice randomized double-blind study. I’m willing to bet on the outcome of that one. You just have to be very careful to keep track of which is the placebo.

Le sigh. Such an RCT would either be unethical or a waste of time depending on how you look at it. If it used sub-Avagadro dilutions of a potentially harmful substance it'd be terribly unethical, if it used sugar pills it'd be pointless. If it's related to manufacturing issues (i.e. purity, adulterants, etc) that's not how you use an RCT. As I mentioned previously the whole idea behind SBM as an expansion on EBM is that RCT's are NOT our only tool. For being so concerned about me personally wasting my effort you sure seem eager to recommending wasting institutional and federal level resources gathering uneccessary data.

By capnkrunch (not verified) on 02 Apr 2015 #permalink

Me, I mock both sides, as you can see.

It's called cynicism.

There might be a less effective way of looking at things than that somewhere in the mists of history. But off the top of my head, I can't think what it is.

...

I suppose it has some limited utility for recreational purposes, if you're witty. Though.

Also, homeopathic preparations shouldn't be able to list something as an ingredient if it isn't actually there.
That's deceptive because with non-homeopathic products, if something is listed as an "ingredient", that means some of it is in the product.
Oscillococcinum still has "Anas barbariae" claimed as an active ingredient - in 200CK dilution!

capnkrunch,

As I mentioned previously the whole idea behind SBM as an expansion on EBM is that RCT’s are NOT our only tool.

Once again poor zebra is way out of his depth, trying to bluff his way through an area he knows nothing about, while flailing around accusing all and sundry of ignorance and idiocy. I suspect that's why he rejected the systematic review I posted a link to above, which includes cases of both direct and indirect harm from homeopathy, as "personal anecdotes and speculation“, because it is a review of published case reports and case series. By that standard every RCT is composed of a series of anecdotal observations and cannot be scientific evidence.

By Krebiozen (not verified) on 02 Apr 2015 #permalink

It's strange.
FDA's <a href="http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManu… about homeopathy states

Those products that are offered for treatment of serious disease conditions, must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC.

Asthma is a serious disease condition - it can kill someone.
But, FDA <a href="http://www.fda.gov/Drugs/DrugSafety/ucm438976.htm"also says

OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms.

Why does FDA allow homeopathic products to be sold as treatment for acute asthma symptoms, then?

Ooops, reposting this with links fixed:

It’s strange.
FDA’s policy about homeopathy states

Those products that are offered for treatment of serious disease conditions, must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC.

Asthma is a serious disease condition – it can kill someone.
But, FDA also says

OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms.

Why does FDA allow homeopathic products to be sold as treatment for acute asthma symptoms, then?

Why does FDA allow homeopathic products to be sold as treatment for acute asthma symptoms, then?

Specific enforcement actions regarding labeling per se do occur, but the very nature of the task is Whac-A-Mole.

And Narad now joins the vaxxers and Creationists with the “absence of evidence” argument.... Sorry, you claim harm, you need to prove your claim.

As expected, Mr. Philosophy of Science does not know what happens when an existential quantification is negated, which is to create a universal quantification.

Claiming that there is "no evidence of harm" with respect to the NPDS data is the positive assertion that every entry is bogus. So, do get to proving your claim.

This has probably been posted already, somewhere on RI. . .

Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks

[Posted 03/19/2015] "FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness."

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHum…

(please 'scuze me if the attempt at html flops)

Let's hope the FDA keeps it's hands off of homeopathy and puts it's attention back where it belongs, on the thousands of people who die each year from big pharma. How many people die each year from homeopathy? The only insanity I see is the loss of perspective about the harm between the two. It is quackery to claim a medicine will help if it creates blatant side effects and other meds are continually added out of need to suppress harmful side effects that affect health and the quality of life. What kind of quality of life exist when you become a slave to big pharma whose drugs are do expensive you need insurance to reduce their cost. If homeopathy is so harmful where are the hundreds of deaths form it each year? Let's look at psychotropic drugs, how many mass killings and suicides have happened and those that did them were taking these drugs? How many have done this with homeopathy? Why are so many people flocking to homeopathy? The solution is to fix the broken drug system instead of using homeopathy as a red herring. Then most people would naturally choose to stay with convention instead of seeking homeopathy. As a nurse who cares for aging parents, it is sad to watch my father's world narrow because he has too many pharmaceuticals that are only palliative. His quality of life has reduced, he had not gotten better with each added drug to address side effects. This is the real problem that needs to be addressed then the other problems will naturally not be considered except by the few. What a waste of the tax payers time and money.

My comment was relevant and deleted. Is this s troll site? Only biased responses are are allowed without question? Again, what is the FDA doing about the thousands who die each year from big pharma? Fix the broken medical system and people will not even bother with CAM. As it stands more damage is done with pharmaceutical than homeopathy, herbal medicine and most CAM systems. Using CAM as a distraction from a biased entity like the FDA just reinforces the broken conventional drug system. There is no good reason for the FDA to waste tax payers dollars to have a two day hearing about homeopathic remedies. Please post a link about the "so-called" homeopathic inhalers. Please post the deaths from them too. A friend of mines husband went to ER two weeks ago for what he experienced as major heartburn, he was released with the diagnosis of heartburn. He died this week from a massive heart attack while driving. Fix this broken system and then the FDA will not need to wast our tax payer dollars on evaluating homeopathy which has yet to show the gross damage of the current system.

My comment was relevant and deleted

Comments disappear for awhile when awaiting moderation, that's all.

Let’s look at psychotropic drugs, how many mass killings and suicides have happened and those that did them were taking these drugs?

If someone is violent (against others or themselves) while taking a drug, how do you know it's the fault of the drug?
Medicine is a matter of harm vs benefit. Medical treatments have a risk as well as a benefit.
Maybe other people benefited from taking the drug.

The only insanity I see is the loss of perspective about the harm between the two.

There is no shortage of comments above yours explaining that the issue is CPG 400.400 and making a gesture toward the utter enforcement failure that has become entrenched and not random whining about The Unfairness Of It All.

Enforcing the law as it stands is not a legal novelty. Please do not mention walking alligators without a leash in Little Rock as a diversion.

There is no doubt a homepathic remedy to treat random expressions of panic that it may in fact be possible to have sucked the legal teat raw in the hope that the rest of the world obeyed the same timeless laws of alchemical Latin cosplay cherished by the marks. I suggest that you seek competent homeopathic advice before something else just up and miasms some sort of encapsulated vital-flow cyst that could take ages to dissolve without an expert homeopathic podiatri$t.

My comment was relevant and deleted. Is this s troll site?

No, it is a kind of flypaper for stupid.

By herr doktor bimler (not verified) on 03 Apr 2015 #permalink

Panphila,

Let’s hope the FDA keeps it’s hands off of homeopathy and puts it’s attention back where it belongs, on the thousands of people who die each year from big pharma.

Wouldn't it be better for the FDA to address harms from both conventional and alternative medicine? I have often discussed 'death by medicine' here before. Briefly, most drugs that are responsible for serious adverse events like death either prevent far more deaths than they cause, like insulin and anticoagulants, or offer a dramatic improvement in quality of life like NSAIDs (yes, even Vioxx) and opiates. Also, the vast majority of people who die from adverse drug reactions are very sick and elderly and would undoubtedly have died without any treatment.

People do have to die of something, and this often happens in a hospital with doctors trying to prolong life with heroic measures. Someone who dies of respiratory depression from morphine prescribed to alleviate the pain of terminal cancer may have died due to the drug, strictly speaking, but personally I would prefer that to untreated pain.

How many people die each year from homeopathy?

It's impossible to say, given that most of those deaths will be due to patients not getting timely effective treatment, and will very probably occur in hospitals and be blamed on conventional medicine.

The only insanity I see is the loss of perspective about the harm between the two. It is quackery to claim a medicine will help if it creates blatant side effects and other meds are continually added out of need to suppress harmful side effects that affect health and the quality of life.

Unnecessary polypharmacy is a problem, but in many cases it is a necessary evil since we have an aging population with multiple health issues. Since active life expectancy has been increasing I'm not convinced that the picture often painted by altmed proponents of millions of elderly people incapacitated by polypharmacy is accurate.

What kind of quality of life exist when you become a slave to big pharma whose drugs are do expensive you need insurance to reduce their cost.

An improving quality of active life - see above. As for requiring insurance, that a problem with the US system rather than conventional medicine per se.

If homeopathy is so harmful where are the hundreds of deaths form it each year?

As I wrote above, we don't know for sure (but see the discussion above), because most of the victims of homeopathy will end up in the emergency room with conventional doctors trying to save the life of someone who has left it far too late to get effective treatment. This article explains just how this can happen, with a naturopath prescribing lifestyle changes when there are acute life-threatening issues that need to be addressed..

Let’s look at psychotropic drugs, how many mass killings and suicides have happened and those that did them were taking these drugs? How many have done this with homeopathy?

Are you suggesting it would be better to treat people with serious mental health issues with homeopathy rather than medications that actually have an effect?

Why are so many people flocking to homeopathy?

Because it falsely claims to cure conditions for which conventional medicine honestly admits it can only offer symptomatic relief, or only a small chance of success.

The solution is to fix the broken drug system instead of using homeopathy as a red herring. Then most people would naturally choose to stay with convention instead of seeking homeopathy.

I very much doubt that is the case when homeopaths continue to make false claims about homeopathy's effectiveness.

As a nurse who cares for aging parents, it is sad to watch my father’s world narrow because he has too many pharmaceuticals that are only palliative. His quality of life has reduced, he had not gotten better with each added drug to address side effects.

You have my sympathy; I had a similar experience with my mother in her final years. If you really believe that the drugs your father is being prescribed are doing more harm than good why not talk to his doctor about this to see which of them might be safely discontinued? Has it occurred to you that his decline may be part of the aging process or due to chronic degenerative conditions, rather than to the drugs he is on? I think this is often the case, just as chemotherapy is often blamed for symptoms that are really due to the cancer.

This is the real problem that needs to be addressed then the other problems will naturally not be considered except by the few. What a waste of the tax payers time and money.

I know many people believe it is the failings of conventional medicine that drive people to altmed but as I wrote above I strongly suspect it is that homeopathy claims to cure conditions for which conventional medicine can only offer symptomatic relief, 'naturally' and without side effects. If it really could do this it would be fantastic, but it can't, and when it fails it is often conventional medicine that has to clean up the mess and ultimately gets the blame.

By Krebiozen (not verified) on 04 Apr 2015 #permalink

panphila: "There is no good reason for the FDA to waste tax payers dollars to have a two day hearing about homeopathic remedies."

Yeah, sure. Like a relative who got off her real meds and bought over priced homeopathic crud from a naturopath. She got worse not better.

Then there are the "results" from homeopathy for Jacqueline Alderslade, Penelope Dingle, Gloria Thomas, Lucille Craven, Isabella Denley, President Warren G. Harding, Paul Howie, Russell Jenkins, Mary Nedlouf, Diane Picha, Janeza Podgoršek, Katie Ross, and many many more.

Krebiozen,

"I know many people believe it is the failings of conventional medicine that drive people to altmed but as I wrote above I strongly suspect it is that homeopathy claims to cure conditions for which conventional medicine can only offer symptomatic relief, ‘naturally’ and without side effects."

Most likely a bit of both of those reasons but a different mix for each individual.

However, I think it is more complex than that to include things like an outright sense of betrayal.

http://www.citizen.org/documents/2245.pdf

TrUTH,

However, I think it is more complex than that to include things like an outright sense of betrayal.

Maybe, but I don't really understand how a lack of faith in the regulation of the advertising of medicines to doctors leads to a belief that conventional medicine is dangerous and ineffective and that homeopathy works. I'm very unhappy with the petrochemical industry for various reasons, but that doesn't lead me to travel by magic carpet, or to deny that the internal combustion engine works.

Anyway, I would hope that my doctor is aware that drug companies will spin their products to look as alluring as possible, and keeps up with the medical literature (isn't that what CME is all about?).

BTW, that proposed guidance from the FDA looks perfectly reasonable to me. Let's say drug X appears to have an association with condition Y in pre-marketing studies, and this information is included on the package insert. Why shouldn't a drug company point out that a large double blind placebo controlled study has subsequently found no link between drug X and condition Y? The document lays out very clearly what quality of evidence is sufficient for a drug company to do this and how it must be presented; separate from any promotional material with any COIs the authors have clearly stated etc.. Some of the commenters on that proposal seem to have completely misunderstood what it means, referring to "reckless misuse of information to promote sales and profits".

By Krebiozen (not verified) on 05 Apr 2015 #permalink

Krebiozen,

My mistake. This covers all of alt med not just homeopathy which I don't understand how anyone could ever believe in.

I don't see things like this particular FDA guidance as encouraging the idea that alt med works but rather as a driver to look for something other than conventional medicine because of lack of trust.

I don't know if the document lays out the quality of evidence required or the drug companies are practicing CYA but of the two comments I read from the drug companies both were requesting specific information on what is allowed with one asking for examples of studies that fit the criteria.

To me this guidance looks like a convoluted, uneven way of updating information regarding a medication. I don't know enough about the change process at the FDA but on the face of it, it seems more logical to just update the package insert.

An improving quality of active life

There is a big problem with people causing themselves premature death and disability, but it's because of their bad habits - smoking, drinking too much, driving too much and exercising too little, eating too much and eating unhealthy foods.
But people like to find something outside themselves to blame.
And there are outside cultural forces, advertising, etc. driving those bad habits.
But pharmaceuticals aren't the cause. A bandaid in some cases, but not the cause.

I don’t really understand how a lack of faith in the regulation of the advertising of medicines to doctors leads to a belief that conventional medicine is dangerous and ineffective and that homeopathy works.

I have been very, very badly let down by mainstream medicine. Starting from when I was 20, I was sick a lot of the time from allergies. But I have untypical and nonspecific allergy symptoms - feeling sick, mental fog. My late-phase allergic reactions have been severe all my life, and the immediate allergic reactions much more mild. Unfortunately, late-phase allergic reactions tend to be nonspecific - mental fog, low energy, etc. - rather than obvious allergy symptoms like sneezing, nasal itching, etc.
So it took me many years even to get diagnosed with allergies, and even then I wasn't helped much. I got allergy shots for years, but they made me sick and the doctors mismanaged them, so that didn't work.
So I continued on the "allergic march", gradually getting sicker. And recently, it got much worse, when my allergy testing temporarily became negative - due to chronic allergic reactions, I believe - and allergists who weren't keeping up with their field told me allergies were unlikely to be the cause of my problems.
I'm finally getting real help - in my 50's now - getting allergy shots and persevering even though they make me sick, with the help of medications.
But even though mainstream med has been so ineffective for me - I STILL haven't had any inclination to look to alt-med for answers. The quality control is much worse with alt-med, not better.
When I found out about my delayed-reaction food allergies, I did think "Gee, I could have gotten better clues from the buzz at the health food store than from my doctors". But that's only a very partial truth. That did make me pay more attention to people's reports of their experiences.
Why would some people think the answer lies in alt-med, if mainstream medicine hasn't helped?
People want to put their faith in something, that's part of it.
It's too anxiety-provoking to think that mainstream medicine is flawed and alt-med is a lot more flawed.
And partly, they aren't science-literate. I have very good science training and I was brought up to value science a lot. So I don't like treatments that aren't supported by at least some science. And I know to dismiss totally implausible treatments like homeopathy.
I'm in great health in terms of the main causes of chronic illness. No metabolic syndrome, I eat plenty of fruits & vegetables, not overweight, I get around on my bicycle for exercise. That was the easy part.

...not just homeopathy which I don’t understand how anyone could ever believe in.

Speaking only for myself (but it's a human trait to think that everyone else shares your beliefs), but back in the day, when I thought of homeopathy at all, I thought it was 'small, controlled doses of herbal medicine'. I never used it, but that's how I would have defined it.

Sure, I now know that the dose is so small as to be nonexistent. I think that if there was a nationwide campaign to get that truth out that it would seriously cut into homeopathic sells.

For example, I think that after hearing Mark Crislip describe how oscillococcinum is made (see
http://www.pusware.com/quackcast/quackcast57.mp3 because the world needs more Mark Crislip) nobody would buy it.

Of course, the question is 'who would pay for the campaign?'.