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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.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

262 replies on “Regulating magic: The FDA considers revamping its regulation of homeopathic products”

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?

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.

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.

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.

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 [email protected]$$ 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.

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?

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?

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.

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

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.”

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.

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. 😉

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).

The second link was broken as well as being unclosed. One more time:
—–
(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.

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.

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).

@ 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.

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

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!

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?

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.

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?

#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-nosodes-are-they-useful-bioterrorism”)

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.

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”).

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.

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

http://respectfulinsolence.com/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.

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.

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.

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